Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c...
FDA Device Recall #Z-1067-2023 — Class II — November 17, 2022
Recall Summary
| Recall Number | Z-1067-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | November 17, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 12,964 cases (23,379 units) |
Product Description
Sterile Procedural Trays, labeled as the following: a. EP LAB PACEMAKER PACK b. OPEN HEART CDS c. OPEN HEART CDS d. AAA CDS e. OPEN HEART CDS f. PACEMAKER CDS g. HEART CDS h. VALVE PACK i. OPEN HEART CDS-3 j. OPEN HEART PACK k. OPEN HEART PACK l. OPEN HEART ADULT m. OPEN HEART CDS PART A n. GLENNON OPEN HEART CDS o. OPEN HEART CDS p. MEMORIAL MED CTR BYPASS q. OPEN HEART PEDS r. OPEN HEART CDS-4 s. OPEN HEART t. CAB CDS u. VASCULAR CDS v. VALVE CDS w. OPEN HEART PACK-LF x. VASCULAR CDS-LF y. OPEN HEART B CDS-LF z. CRANIOTOMY CDS aa. OPEN UROLOGY CDS-LF bb. TOTAL KNEE CDS cc. LOWER EXTREMITY CDS-LF dd. LAMINECTOMY CDS ee. ENDOVASCULAR CDS ff. VASCULAR gg. VASCULAR CDS-3 hh. VASCULAR ACCESS CDS ii. ZALE PUMP CDS jj. CUH ENDOVASCULAR CDS kk. CUH MINOR VASCULAR CDS ll. FHT CVOR CABG mm. OPEN HEART CDS nn. OPEN HEART CDS oo. CAROTID ENDARTERECTOMY CDS-LF pp. PACER CDS qq. PERIPHERAL VASCULAR CDS rr. ACH OPEN HEART ss. ACH OPEN HEART tt. OPEN HEART CDS uu. VASCULAR CDS vv. CV CDS ww. OPEN HEART CABG PACK-LF xx. MAJOR VASCULAR PACK-LF yy. CARDIOVASCULAR PACK-LF zz. VASCULAR HARPER PACK-LF aaa. CABG 1 OR 2 HARPER PACK bbb. TAVR 1 PACK-LF ccc. ENDO VASCULAR PACK-LF ddd. OPEN HEART A & B PACK eee. PACEMAKER IMPLANT PACK-LF fff. PERIPHERAL VASCULAR PACK-LF ggg. PACEMAKER PACK-LF hhh. RR-NEURO VASCULAR PACK-LF iii. CARDIAC CHEST PACK 80701 jjj. OPEN HEART PACK-LF kkk. PACEMAKER PACK-LF lll. CARDIOVASCULAR PACK-LF mmm. OPEN HEART PACK A & B nnn. MINOR VASCULAR PACK ooo. OPEN HEART PACK-LF ppp. SMALL VASCULAR PACK-LF qqq. MAJOR VASCULAR PACK-LF rrr. PEDIATRIC CARDIAC PACK-LF sss. OH VALVE PACK-LF ttt. HEART OVERHEAD TABLE PACK uuu. OPEN HEART PACK vvv. PACEMAKER PACK-LF www. VASCULAR PACK-LF xxx. OPEN HEART PACK yyy. VASCULAR PACK zzz. CV BASIC SET UP PACK aaaa. UNIVERSAL OPEN HEART PACK bbbb. VASCULAR BYPASS PACK-LF cccc. BMC CABG PACK A dddd. CUSTOM CAROTID eeee. A-V FISTULA PACK-LF ffff. PERIPHERAL VASCULAR PACK-LF gggg. ECMO PACK hhhh. HEART PACK iiii. CABG PACK A&B jjjj. OPEN HEART PACK kkkk. CV A & B llll. PEDIATRIC OPEN HEART-NS-LF mmmm. PACEMAKER NORTH nnnn. OPEN HEART PACK oooo. SVMMC CORE OPEN HEART PACK-LF pppp. PACEMAKER TRAY-LF qqqq. PACEMAKER PACK rrrr. MAJOR VASCULAR-RF-LF ssss. AV FISTULA-LF tttt. PACEMAKER PACK uuuu. VASCULAR PACK vvvv. PACEMAKER wwww. MAJOR VASCULAR PACK xxxx. MAJOR VASCULAR PACK yyyy. VASCULAR PACK zzzz. PACEMAKER PACK-LF aaaaa. RRMC CABG AUXILIARY TRAY bbbbb. RRMC OPEN HEART PACK ccccc. MAJOR VASCULAR PACK ddddd. PACEMAKER PACK eeeee. PACEMAKER TRAY fffff. PACEMAKER PACK ggggg. PACEMAKER PACK hhhhh. AV FISTULA PK-LF iiiii. FHT PACER PACK jjjjj. PACEMAKER SET UP PACK kkkkk. MAJOR VASCULAR PACK lllll. PACEMAKER PACK-LF mmmmm. CAROTID PACK nnnnn. MAJOR VASCULAR PACK ooooo. VASCULAR PACK GH-LF ppppp. A-V FISTULA PACK GH-LF qqqqq. VASCULAR PACK MH-LF rrrrr. PACEMAKER PACK L J sssss. OPEN HEART ttttt. OPEN HEART SUPPLY TRAY uuuuu. PACEMAKER PACK vvvvv. PACEMAKER PACK wwwww. VASCULAR PACK xxxxx. BASIC OPEN HEART PACK A B yyyyy. VASCULAR PACK zzzzz. OPEN HEART TRAY A-LF aaaaaa. VASCULAR PACK bbbbbb. PACEMAKER PACK cccccc. OPEN HEART PACK dddddd. ENDOVASCULAR PACK-LF eeeeee. VASCULAR PACK-LF ffffff. BASIC OPEN HEART PACK-LF gggggg. OPEN VASCULAR PACK-LF hhhhhh. PK, EP LAB PACEMAKER iiiiii. PK, OPEN HEART-CABG jjjjjj. OPEN HEART PACK kkkkkk. PK, OPEN HEART- A&B llllll. SVMMC VASCULAR MAJOR PACK mmmmmm. CV PACK nnnnnn. OPEN HEART PACK A AND B oooooo. SVMMC CAROTID PACK pppppp. PK, OPEN HEART-CABG A&B qqqqqq. PK, OPEN HEART-A&B rrrrrr. VASCULAR PACK ssssss. PK, OPEN HEART tttttt. PK, OPEN HEART uuuuuu. OPEN HEART PACK vvvvvv. PK, OPEN HEART-A&B wwwwww. OPEN HEART PACK xxxxxx. PK, OPEN HEART-CABG yyyyyy. PK, OPEN HEART zzzzzz. CASTRO CABG-COMPONENT PACK aaaaaaa. RE-ENTRY PACK bbbbbbb. HEART PACK ccccccc. OPEN HEART SUPPLY PACK ddddddd. PK, OPEN HEART-CABG eeeeeee. CABG PROCEDURE PACK fffffff. CABG PACK ggggggg. PK, OPEN HEART hhhhhhh. VASCULAR GRAFT PACK iiiiiii. PK, OPEN HEART jjjjjjj. VASCULAR PACK kkkkkkk. PK,
Reason for Recall
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Lot / Code Information
a. EP LAB PACEMAKER PACK, Item Number: 00-401893L, Case UDI/GTIN: 40195327127887, Unit UDI/GTIN: 10195327127886, Lot Number: 22JMC769; b. OPEN HEART CDS, Item Number: CDS840016AD, Case UDI/GTIN: 40193489741842, Unit UDI/GTIN: 10193489741841, Lot Number: 22KBB889; c. OPEN HEART CDS, Item Number: CDS840023T, Case UDI/GTIN: 40193489682060, Unit UDI/GTIN: 10193489682069, Lot Number: 22JBU353,22JBT770; d. AAA CDS, Item Number: CDS840076AC, Case UDI/GTIN: 40195327209620, Unit UDI/GTIN: 10195327209629, Lot Number: 22KBE518; e. OPEN HEART CDS, Item Number: CDS840094N, Case UDI/GTIN: 40195327089512, Unit UDI/GTIN: 10195327089511, Lot Number: 22JBI258,22IBF817; f. PACEMAKER CDS, Item Number: CDS840162V, Case UDI/GTIN: 40193489480628, Unit UDI/GTIN: 10193489480627, Lot Number: 22KBG388,22IBP339; g. HEART CDS, Item Number: CDS840179M, Case UDI/GTIN: 40889942894001, Unit UDI/GTIN: 10889942894000, Lot Number: 22JBJ710,22IBQ944; h. VALVE PACK, Item Number: CDS840187T, Case UDI/GTIN: 40193489816465, Unit UDI/GTIN: 10193489816464, Lot Number: 22JMG653; i. OPEN HEART CDS-3, Item Number: CDS840246N, Case UDI/GTIN: 40889942217428, Unit UDI/GTIN: 10889942217427, Lot Number: 22JLB009,22JLA126,22ILB075; j. OPEN HEART PACK, Item Number: CDS840332Y, Case UDI/GTIN: 40195327259298, Unit UDI/GTIN: 10195327259297, Lot Number: 22KLA079; k. OPEN HEART PACK, Item Number: CDS840393M, Case UDI/GTIN: 40195327188543, Unit UDI/GTIN: 10195327188542, Lot Number: 22KBD842; l. OPEN HEART ADULT, Item Number: CDS840396X, Case UDI/GTIN: 40193489461917, Unit UDI/GTIN: 10193489461916, Lot Number: 22JBG072,22JBG077,22JBG079; m. OPEN HEART CDS PART A, Item Number: CDS840402AG, Case UDI/GTIN: 40195327255115, Unit UDI/GTIN: 10195327255114, Lot Number: 22JLA474; n. GLENNON OPEN HEART CDS, Item Number: CDS840412N, Case UDI/GTIN: 40195327072231, Unit UDI/GTIN: 10195327072230, Lot Number: 22JBG206; o. OPEN HEART CDS, Item Number: CDS840483K, Case UDI/GTIN: 40888277749796, Unit UDI/GTIN: 10888277749795, Lot Number: 22IBR228; p. MEMORIAL MED CTR BYPASS, Item Number: CDS901660, Case UDI/GTIN: 40888277814111, Unit UDI/GTIN: 10888277814110, Lot Number: 22KBA999,22JBL553; q. OPEN HEART PEDS, Item Number: CDS981050Q, Case UDI/GTIN: 40889942864660, Unit UDI/GTIN: 10889942864669, Lot Number: 22JBH010,22IBC746,22IBC748; r. OPEN HEART CDS-4, Item Number: CDS981159J, Case UDI/GTIN: 40889942215110, Unit UDI/GTIN: 10889942215119, Lot Number: 22JLA895,22ILA228; s. OPEN HEART, Item Number: CDS981161AB, Case UDI/GTIN: 40193489817462, Unit UDI/GTIN: 10193489817461, Lot Number: 22JBT785; t. CAB CDS, Item Number: CDS981533G, Case UDI/GTIN: 40195327171422, Unit UDI/GTIN: 10195327171421, Lot Number: 22JBW502; u. VASCULAR CDS, Item Number: CDS981545F, Case UDI/GTIN: 40193489975407, Unit UDI/GTIN: 10193489975406, Lot Number: 22JBU076,22JBU077; v. VALVE CDS, Item Number: CDS981551D, Case UDI/GTIN: 40195327171439, Unit UDI/GTIN: 10195327171438, Lot Number: 22JBR297,22IBS787; w. OPEN HEART PACK-LF, Item Number: CDS981662J, Case UDI/GTIN: 40195327014538, Unit UDI/GTIN: 10195327014537, Lot Number: 22JBV196; x. VASCULAR CDS-LF, Item Number: CDS982412O, Case UDI/GTIN: 40195327212378, Unit UDI/GTIN: 10195327212377, Lot Number: 22IBB001,22IBB003; y. OPEN HEART B CDS-LF, Item Number: CDS982423L, Case UDI/GTIN: 40193489419802, Unit UDI/GTIN: 10193489419801, Lot Number: 22JBQ337; z. CRANIOTOMY CDS, Item Number: CDS982480P, Case UDI/GTIN: 40195327195671, Unit UDI/GTIN: 10195327195670, Lot Number: 22IDB602; aa. OPEN UROLOGY CDS-LF, Item Number: CDS982482I, Case UDI/GTIN: 40195327071777, Unit UDI/GTIN: 10195327071776, Lot Number: 22JDB005,22IDB497; bb. TOTAL KNEE CDS, Item Number: CDS982486M, Case UDI/GTIN: 40195327092345, Unit UDI/GTIN: 10195327092344, Lot Number: 22KDA380; cc. LOWER EXTREMITY CDS-LF, Item Number: CDS982489J, Case UDI/GTIN: 40195327090754, Unit UDI/GTIN: 10195327090753, Lot Number: 22JDB330,22IDB911; dd. LAMINECTOMY CDS, Item Number: CDS982491Q, Case UDI/GTIN: 40195327195725, Unit UDI/GTIN: 10195327195724, Lot Number: 22JDB539,22JDA137; ee. ENDOVASCULAR CDS, Item Number: CDS982659M, Case UDI/GTIN: 40193489204187, Unit UDI/GTIN: 10193489204186, Lot Number: 22KLA219,22JLB019,22ILB085; ff. VASCULAR, Item Number: CDS982699J, Case UDI/GTIN: 40193489418102, Unit UDI/GTIN: 10193489418101, Lot Number: 22KBB744,22KBB751,22KBB749; gg. VASCULAR CDS-3, Item Number: CDS983002D, Case UDI/GTIN: 40889942000433, Unit UDI/GTIN: 10889942000432, Lot Number: 22JLA875,22ILA255; hh. VASCULAR ACCESS CDS, Item Number: CDS983105D, Case UDI/GTIN: 40193489635509, Unit UDI/GTIN: 10193489635508, Lot Number: 22JBC333; ii. ZALE PUMP CDS, Item Number: CDS983187G, Case UDI/GTIN: 40195327258529, Unit UDI/GTIN: 10195327258528, Lot Number: 22JBX916; jj. CUH ENDOVASCULAR CDS, Item Number: CDS983192G, Case UDI/GTIN: 40193489699068, Unit UDI/GTIN: 10193489699067, Lot Number: 22JBF027,22HBY314; kk. CUH MINOR VASCULAR CDS, Item Number: CDS983196G, Case UDI/GTIN: 40195327164660, Unit UDI/GTIN: 10195327164669, Lot Number: 22JBT201,22IBB523; ll. FHT CVOR CABG, Item Number: CDS983346I, Case UDI/GTIN: 40193489929332, Unit UDI/GTIN: 10193489929331, Lot Number: 22IBU546; mm. OPEN HEART CDS, Item Number: CDS983451Q, Case UDI/GTIN: 40195327165186, Unit UDI/GTIN: 10195327165185, Lot Number: 22JBY402; nn. OPEN HEART CDS, Item Number: CDS983513F, Case UDI/GTIN: 40193489843720, Unit UDI/GTIN: 10193489843729, Lot Number: 22IBD426; oo. CAROTID ENDARTERECTOMY CDS-LF, Item Number: CDS983637I, Case UDI/GTIN: 40195327228126, Unit UDI/GTIN: 10195327228125, Lot Number: 22KBC672; pp. PACER CDS, Item Number: CDS983686I, Case UDI/GTIN: 40193489852982, Unit UDI/GTIN: 10193489852981, Lot Number: 22JBL438,22IBU735; qq. PERIPHERAL VASCULAR CDS, Item Number: CDS983723I, Case UDI/GTIN: 40195327228157, Unit UDI/GTIN: 10195327228156, Lot Number: 22JBR360,22IBP608; rr. ACH OPEN HEART, Item Number: CDS983773I, Case UDI/GTIN: 40193489847124, Unit UDI/GTIN: 10193489847123, Lot Number: 22IBJ338; ss. ACH OPEN HEART, Item Number: CDS983773J, Case UDI/GTIN: 40195327233618, Unit UDI/GTIN: 10195327233617, Lot Number: 22JBH775; tt. OPEN HEART CDS, Item Number: CDS984355G, Case UDI/GTIN: 40193489484633, Unit UDI/GTIN: 10193489484632, Lot Number: 22JLB146,22ILB092,22ILA721; uu. VASCULAR CDS, Item Number: CDS985215D, Case UDI/GTIN: 40195327110797, Unit UDI/GTIN: 10195327110796, Lot Number: 22IBR023,22IBA153; vv. CV CDS, Item Number: CDS985395D, Case UDI/GTIN: 40193489859714, Unit UDI/GTIN: 10193489859713, Lot Number: 22JBI301,22IBU577; ww. OPEN HEART CABG PACK-LF, Item Number: DYNJ0149567C, Case UDI/GTIN: 40195327235520, Unit UDI/GTIN: 10195327235529, Lot Number: 22IBD436; xx. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0151111B, Case UDI/GTIN: 40889942050797, Unit UDI/GTIN: 10889942050796, Lot Number: 22IDB491,22IDA147; yy. CARDIOVASCULAR PACK-LF, Item Number: DYNJ0160327B, Case UDI/GTIN: 40889942051770, Unit UDI/GTIN: 10889942051779, Lot Number: 22JDA346; zz. VASCULAR HARPER PACK-LF, Item Number: DYNJ0160636F, Case UDI/GTIN: 40193489205566, Unit UDI/GTIN: 10193489205565, Lot Number: 22IDA733,22HDC250; aaa. CABG 1 OR 2 HARPER PACK, Item Number: DYNJ0160742D, Case UDI/GTIN: 40195327005970, Unit UDI/GTIN: 10195327005979, Lot Number: 22IDB925,22HDA618; bbb. TAVR 1 PACK-LF, Item Number: DYNJ0170415G, Case UDI/GTIN: 40195327167685, Unit UDI/GTIN: 10195327167684, Lot Number: 22HMD027; ccc. ENDO VASCULAR PACK-LF, Item Number: DYNJ0236704N, Case UDI/GTIN: 40193489720670, Unit UDI/GTIN: 10193489720679, Lot Number: 22IME561; ddd. OPEN HEART A & B PACK, Item Number: DYNJ0236832P, Case UDI/GTIN: 40193489404631, Unit UDI/GTIN: 10193489404630, Lot Number: 22HMB796; eee. PACEMAKER IMPLANT PACK-LF, Item Number: DYNJ0373237M, Case UDI/GTIN: 40193489369015, Unit UDI/GTIN: 10193489369014, Lot Number: 22JBO014; fff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ0375688L, Case UDI/GTIN: 40193489724258, Unit UDI/GTIN: 10193489724257, Lot Number: 22JBI091; ggg. PACEMAKER PACK-LF, Item Number: DYNJ0378729F, Case UDI/GTIN: 40888277763310, Unit UDI/GTIN: 10888277763319, Lot Number: 22IMB260; hhh. RR-NEURO VASCULAR PACK-LF, Item Number: DYNJ0394874L, Case UDI/GTIN: 40193489800006, Unit UDI/GTIN: 10193489800005, Lot Number: 22GLB222; iii. CARDIAC CHEST PACK 80701, Item Number: DYNJ04439N, Case UDI/GTIN: 40195327160303, Unit UDI/GTIN: 10195327160302, Lot Number: 22JBI819; jjj. OPEN HEART PACK-LF, Item Number: DYNJ04506V, Case UDI/GTIN: 40193489510318, Unit UDI/GTIN: 10193489510317, Lot Number: 22JMC546; kkk. PACEMAKER PACK-LF, Item Number: DYNJ04516N, Case UDI/GTIN: 40888277744517, Unit UDI/GTIN: 10888277744516, Lot Number: 22JMH689,22IMF834; lll. CARDIOVASCULAR PACK-LF, Item Number: DYNJ04676T, Case UDI/GTIN: 40193489805742, Unit UDI/GTIN: 10193489805741, Lot Number: 22JMD285; mmm. OPEN HEART PACK A & B, Item Number: DYNJ04822R, Case UDI/GTIN: 40195327188178, Unit UDI/GTIN: 10195327188177, Lot Number: 22JBC142; nnn. MINOR VASCULAR PACK, Item Number: DYNJ04852O, Case UDI/GTIN: 40193489303897, Unit UDI/GTIN: 10193489303896, Lot Number: 22IMF450; ooo. OPEN HEART PACK-LF, Item Number: DYNJ0530912AK, Case UDI/GTIN: 40195327167661, Unit UDI/GTIN: 10195327167660, Lot Number: 22IBO170; ppp. SMALL VASCULAR PACK-LF, Item Number: DYNJ0536987AC, Case UDI/GTIN: 40195327170616, Unit UDI/GTIN: 10195327170615, Lot Number: 22JMF083; qqq. MAJOR VASCULAR PACK-LF, Item Number: DYNJ0536993AI, Case UDI/GTIN: 40195327167630, Unit UDI/GTIN: 10195327167639, Lot Number: 22IBG292; rrr. PEDIATRIC CARDIAC PACK-LF, Item Number: DYNJ0537013AA, Case UDI/GTIN: 40195327167678, Unit UDI/GTIN: 10195327167677, Lot Number: 22JMC081; sss. OH VALVE PACK-LF, Item Number: DYNJ0541850O, Case UDI/GTIN: 40195327167654, Unit UDI/GTIN: 10195327167653, Lot Number: 22IBS422; ttt. HEART OVERHEAD TABLE PACK, Item Number: DYNJ0778508I, Case UDI/GTIN: 40195327049462, Unit UDI/GTIN: 10195327049461, Lot Number: 22IME042; uuu. OPEN HEART PACK, Item Number: DYNJ0826299T, Case UDI/GTIN: 40193489377980, Unit UDI/GTIN: 10193489377989, Lot Number: 22IBB762,22HBO328; vvv. PACEMAKER PACK-LF, Item Number: DYNJ0826630L, Case UDI/GTIN: 40195327177073, Unit UDI/GTIN: 10195327177072, Lot Number: 22IMH402,22IMF458; www. VASCULAR PACK-LF, Item Number: DYNJ0901358J, Case UDI/GTIN: 40195327156559, Unit UDI/GTIN: 10195327156558, Lot Number: 22IDA821; xxx. OPEN HEART PACK, Item Number: DYNJ0911264O, Case UDI/GTIN: 40195327124329, Unit UDI/GTIN: 10195327124328, Lot Number: 22IBQ743,22HBY040; yyy. VASCULAR PACK, Item Number: DYNJ14078F, Case UDI/GTIN: 40193489927840, Unit UDI/GTIN: 10193489927849, Lot Number: 22IBI839; zzz. CV BASIC SET UP PACK, Item Number: DYNJ14224F, Case UDI/GTIN: 40193489927680, Unit UDI/GTIN: 10193489927689, Lot Number: 22JBS669; aaaa. UNIVERSAL OPEN HEART PACK, Item Number: DYNJ14225F, Case UDI/GTIN: 40888277944078, Unit UDI/GTIN: 10888277944077, Lot Number: 22HBG261; bbbb. VASCULAR BYPASS PACK-LF, Item Number: DYNJ17470G, Case UDI/GTIN: 40195327224555, Unit UDI/GTIN: 10195327224554, Lot Number: 22JBW106,22JBD564,22IBM206; cccc. BMC CABG PACK A, Item Number: DYNJ17475J, Case UDI/GTIN: 40195327224807, Unit UDI/GTIN: 10195327224806, Lot Number: 22IBN857,22IBA835,22HBO577,22HBP255; dddd. CUSTOM CAROTID, Item Number: DYNJ20266K, Case UDI/GTIN: 40195327052943, Unit UDI/GTIN: 10195327052942, Lot Number: 22IBJ739; eeee. A-V FISTULA PACK-LF, Item Number: DYNJ20502P, Case UDI/GTIN: 40195327024414, Unit UDI/GTIN: 10195327024413, Lot Number: 22JDB304,22IDC077,22IDA958,22IDA175; ffff. PERIPHERAL VASCULAR PACK-LF, Item Number: DYNJ20503P, Case UDI/GTIN: 40195327024605, Unit UDI/GTIN: 10195327024604, Lot Number: 22IDA018; gggg. ECMO PACK, Item Number: DYNJ21245N, Case UDI/GTIN: 40193489935708, Unit UDI/GTIN: 10193489935707, Lot Number: 22JBM468,22HBQ114; hhhh. HEART PACK, Item Number: DYNJ21246P, Case UDI/GTIN: 40193489935715, Unit UDI/GTIN: 10193489935714, Lot Number: 22HBK069; iiii. CABG PACK A&B, Item Number: DYNJ21971AD, Case UDI/GTIN: 40195327227051, Unit UDI/GTIN: 10195327227050, Lot Number: 22JDA281,22IDA306; jjjj. OPEN HEART PACK, Item Number: DYNJ22035K, Case UDI/GTIN: 40889942029052, Unit UDI/GTIN: 10889942029051, Lot Number: 22IBQ625,22IBE372,22HBT001; kkkk. CV A & B, Item Number: DYNJ22215M, Case UDI/GTIN: 40195327058068, Unit UDI/GTIN: 10195327058067, Lot Number: 22HDB323; llll. PEDIATRIC OPEN HEART-NS-LF, Item Number: DYNJ22230Q, Case UDI/GTIN: 40193489962728, Unit UDI/GTIN: 10193489962727, Lot Number: 22IBQ407,22HBP292,22HBP293,22HBP295; mmmm. PACEMAKER NORTH, Item Number: DYNJ22388F, Case UDI/GTIN: 40889942598510, Unit UDI/GTIN: 10889942598519, Lot Number: 22HBX429; nnnn. OPEN HEART PACK, Item Number: DYNJ22851D, Case UDI/GTIN: 40884389685229, Unit UDI/GTIN: 10884389685228, Lot Number: 22HBP275; oooo. SVMMC CORE OPEN HEART PACK-LF, Item Number: DYNJ22971T, Case UDI/GTIN: 40195327136834, Unit UDI/GTIN: 10195327136833, Lot Number: 22IBO902; pppp. PACEMAKER TRAY-LF, Item Number: DYNJ23050C, Case UDI/GTIN: 40193489948449, Unit UDI/GTIN: 10193489948448, Lot Number: 22JMG953,22IMI497,22IMB289; qqqq. PACEMAKER PACK, Item Number: DYNJ24836M, Case UDI/GTIN: 40889942532477, Unit UDI/GTIN: 10889942532476, Lot Number: 22JBK563; rrrr. MAJOR VASCULAR-RF-LF, Item Number: DYNJ24932P, Case UDI/GTIN: 40195327160150, Unit UDI/GTIN: 10195327160159, Lot Number: 22IBT463; ssss. AV FISTULA-LF, Item Number: DYNJ24944K, Case UDI/GTIN: 40195327045310, Unit UDI/GTIN: 10195327045319, Lot Number: 22IBO282; tttt. PACEMAKER PACK, Item Number: DYNJ25865F, Case UDI/GTIN: 40193489387095, Unit UDI/GTIN: 10193489387094, Lot Number: 22JBJ504,22JBK347,22IBU602; uuuu. VASCULAR PACK, Item Number: DYNJ27559O, Case UDI/GTIN: 40195327155507, Unit UDI/GTIN: 10195327155506, Lot Number: 22JBS418; vvvv. PACEMAKER, Item Number: DYNJ27798D, Case UDI/GTIN: 40889942000532, Unit UDI/GTIN: 10889942000531, Lot Number: 22JBI655; wwww. MAJOR VASCULAR PACK, Item Number: DYNJ31398M, Case UDI/GTIN: 40193489735001, Unit UDI/GTIN: 10193489735000, Lot Number: 22ILA207; xxxx. MAJOR VASCULAR PACK, Item Number: DYNJ31398N, Case UDI/GTIN: 40195327259281, Unit UDI/GTIN: 10195327259280, Lot Number: 22JLA632,22JLA374; yyyy. VASCULAR PACK, Item Number: DYNJ31902L, Case UDI/GTIN: 40193489776073, Unit UDI/GTIN: 10193489776072, Lot Number: 22IBU515,22HBR178; zzzz. PACEMAKER PACK-LF, Item Number: DYNJ33062B, Case UDI/GTIN: 40884389604732, Unit UDI/GTIN: 10884389604731, Lot Number: 22HBY351; aaaaa. RRMC CABG AUXILIARY TRAY, Item Number: DYNJ33387I, Case UDI/GTIN: 40193489915557, Unit UDI/GTIN: 10193489915556, Lot Number: 22JBF985; bbbbb. RRMC OPEN HEART PACK, Item Number: DYNJ33394M, Case UDI/GTIN: 40193489918640, Unit UDI/GTIN: 10193489918649, Lot Number: 22JBT973,22HBF896; ccccc. MAJOR VASCULAR PACK, Item Number: DYNJ34102D, Case UDI/GTIN: 40193489551953, Unit UDI/GTIN: 10193489551952, Lot Number: 22IME737; ddddd. PACEMAKER PACK, Item Number: DYNJ35201I, Case UDI/GTIN: 40195327134113, Unit UDI/GTIN: 10195327134112, Lot Number: 22JBO409; eeeee. PACEMAKER TRAY, Item Number: DYNJ35519F, Case UDI/GTIN: 40193489809221, Unit UDI/GTIN: 10193489809220, Lot Number: 22JMG600; fffff. PACEMAKER PACK, Item Number: DYNJ36025C, Case UDI/GTIN: 40193489700269, Unit UDI/GTIN: 10193489700268, Lot Number: 22JMI234; ggggg. PACEMAKER PACK, Item Number: DYNJ36312K, Case UDI/GTIN: 40195327156436, Unit UDI/GTIN: 10195327156435, Lot Number: 22JMA898; hhhhh. AV FISTULA PK-LF, Item Number: DYNJ36735D, Case UDI/GTIN: 40195327147229, Unit UDI/GTIN: 10195327147228, Lot Number: 22IBJ526; iiiii. FHT PACER PACK, Item Number: DYNJ37114G, Case UDI/GTIN: 40193489932080, Unit UDI/GTIN: 10193489932089, Lot Number: 22JBO139,22IBS426; jjjjj. PACEMAKER SET UP PACK, Item Number: DYNJ38232, Case UDI/GTIN: 40884389685762, Unit UDI/GTIN: 10884389685761, Lot Number: 22JBV577; kkkkk. MAJOR VASCULAR PACK, Item Number: DYNJ38318F, Case UDI/GTIN: 40193489728515, Unit UDI/GTIN: 10193489728514, Lot Number: 22IME581,22IME054; lllll. PACEMAKER PACK-LF, Item Number: DYNJ38702, Case UDI/GTIN: 40884389709062, Unit UDI/GTIN: 10884389709061, Lot Number: 22HDB882; mmmmm. CAROTID PACK, Item Number: DYNJ39488I, Case UDI/GTIN: 40195327249510, Unit UDI/GTIN: 10195327249519, Lot Number: 22IMD856; nnnnn. MAJOR VASCULAR PACK, Item Number: DYNJ39542F, Case UDI/GTIN: 40193489987646, Unit UDI/GTIN: 10193489987645, Lot Number: 22JMB308,22IMC327; ooooo. VASCULAR PACK GH-LF, Item Number: DYNJ39840C, Case UDI/GTIN: 40195327177080, Unit UDI/GTIN: 10195327177089, Lot Number: 22IMD146,22IMD147; ppppp. A-V FISTULA PACK GH-LF, Item Number: DYNJ39861C, Case UDI/GTIN: 40195327176830, Unit UDI/GTIN: 10195327176839, Lot Number: 22JME917; qqqqq. VASCULAR PACK MH-LF, Item Number: DYNJ39866C, Case UDI/GTIN: 40195327176342, Unit UDI/GTIN: 10195327176341, Lot Number: 22IMH447,22HMH464; rrrrr. PACEMAKER PACK L J, Item Number: DYNJ40024B, Case UDI/GTIN: 40195327176496, Unit UDI/GTIN: 10195327176495, Lot Number: 22JME764,22IMG357,22HMD989,22GMA585; sssss. OPEN HEART, Item Number: DYNJ40976A, Case UDI/GTIN: 40889942431213, Unit UDI/GTIN: 10889942431212, Lot Number: 22JLA725; ttttt. OPEN HEART SUPPLY TRAY, Item Number: DYNJ41007A, Case UDI/GTIN: 40193489305211, Unit UDI/GTIN: 10193489305210, Lot Number: 22IBN535,22IBE489; uuuuu. PACEMAKER PACK, Item Number: DYNJ41094, Case UDI/GTIN: 40884389896168, Unit UDI/GTIN: 10884389896167, Lot Number: 22JBJ333; vvvvv. PACEMAKER PACK, Item Number: DYNJ41189, Case UDI/GTIN: 40884389898254, Unit UDI/GTIN: 10884389898253, Lot Number: 22JBO177; wwwww. VASCULAR PACK, Item Number: DYNJ41397C, Case UDI/GTIN: 40888277950871, Unit UDI/GTIN: 10888277950870, Lot Number: 22HBY320; xxxxx. BASIC OPEN HEART PACK A B, Item Number: DYNJ41485, Case UDI/GTIN: 40884389909585, Unit UDI/GTIN: 10884389909584, Lot Number: 22JBQ405,22IBK720,22IBA814; yyyyy. VASCULAR PACK, Item Number: DYNJ41519A, Case UDI/GTIN: 40888277935243, Unit UDI/GTIN: 10888277935242, Lot Number: 22IBR239,22HBT658; zzzzz. OPEN HEART TRAY A-LF, Item Number: DYNJ42156, Case UDI/GTIN: 40884389913957, Unit UDI/GTIN: 10884389913956, Lot Number: 22JBC984,22IBQ308,22IBH233; aaaaaa. VASCULAR PACK, Item Number: DYNJ42554B, Case UDI/GTIN: 40889942158332, Unit UDI/GTIN: 10889942158331, Lot Number: 22IBO207; bbbbbb. PACEMAKER PACK, Item Number: DYNJ42557B, Case UDI/GTIN: 40889942135807, Unit UDI/GTIN: 10889942135806, Lot Number: 22JBJ624,22HBZ316; cccccc. OPEN HEART PACK, Item Number: DYNJ42580C, Case UDI/GTIN: 40889942816386, Unit UDI/GTIN: 10889942816385, Lot Number: 22HBV705; dddddd. ENDOVASCULAR PACK-LF, Item Number: DYNJ42831F, Case UDI/GTIN: 40193489880329, Unit UDI/GTIN: 10193489880328, Lot Number: 22JBA341,22IBG065; eeeeee. VASCULAR PACK-LF, Item Number: DYNJ42849C, Case UDI/GTIN: 40889942849544, Unit UDI/GTIN: 10889942849543, Lot Number: 22IBG029; ffffff. BASIC OPEN HEART PACK-LF, Item Number: DYNJ43399I, Case UDI/GTIN: 40195327209385, Unit UDI/GTIN: 10195327209384, Lot Number: 22JBI149; gggggg. OPEN VASCULAR PACK-LF, Item Number: DYNJ43414D, Case UDI/GTIN: 40195327136681, Unit UDI/GTIN: 10195327136680, Lot Number: 22JMB316; hhhhhh. PK, EP LAB PACEMAKER, Item Number: DYNJ43663A, Case UDI/GTIN: 40193489793681, Unit UDI/GTIN: 10193489793680, Lot Number: 22JBO225; iiiiii. PK, OPEN HEART-CABG, Item Number: DYNJ43666C, Case UDI/GTIN: 40193489793674, Unit UDI/GTIN: 10193489793673, Lot Number: 22JBT937; jjjjjj. OPEN HEART PACK, Item Number: DYNJ43741B, Case UDI/GTIN: 40889942821076, Unit UDI/GTIN: 10889942821075, Lot Number: 22HBO045; kkkkkk. PK, OPEN HEART- A&B, Item Number: DYNJ43751F, Case UDI/GTIN: 40193489414517, Unit UDI/GTIN: 10193489414516, Lot Number: 22IBO181; llllll. SVMMC VASCULAR MAJOR PACK, Item Number: DYNJ43777J, Case UDI/GTIN: 40193489990189, Unit UDI/GTIN: 10193489990188, Lot Number: 22JBJ507,22IBV692,22IBE494; mmmmmm. CV PACK, Item Number: DYNJ43824, Case UDI/GTIN: 40888277071729, Unit UDI/GTIN: 10888277071728, Lot Number: 22JMC590,22IMD149,22HMD629; nnnnnn. OPEN HEART PACK A AND B, Item Number: DYNJ43858B, Case UDI/GTIN: 40195327200191, Unit UDI/GTIN: 10195327200190, Lot Number: 22IBH029,22HBI610; oooooo. SVMMC CAROTID PACK, Item Number: DYNJ43861F, Case UDI/GTIN: 40193489981644, Unit UDI/GTIN: 10193489981643, Lot Number: 22JBL517; pppppp. PK, OPEN HEART-CABG A&B, Item Number: DYNJ43872A, Case UDI/GTIN: 40889942238942, Unit UDI/GTIN: 10889942238941, Lot Number: 22JBM586; qqqqqq. PK, OPEN HEART-A&B, Item Number: DYNJ43895G, Case UDI/GTIN: 40193489203395, Unit UDI/GTIN: 10193489203394, Lot Number: 22JBM587,22JBJ484,22HBP784; rrrrrr. VASCULAR PACK, Item Number: DYNJ43945I, Case UDI/GTIN: 40193489704243, Unit UDI/GTIN: 10193489704242, Lot Number: 22JMG347,22HMD283; ssssss. PK, OPEN HEART, Item Number: DYNJ43970, Case UDI/GTIN: 40888277077165, Unit UDI/GTIN: 10888277077164, Lot Number: 22JBB067,22IBA908,22HBI904; tttttt. PK, OPEN HEART, Item Number: DYNJ43979A, Case UDI/GTIN: 40889942010784, Unit UDI/GTIN: 10889942010783, Lot Number: 22IBV693; uuuuuu. OPEN HEART PACK, Item Number: DYNJ44025A, Case UDI/GTIN: 40193489204668, Unit UDI/GTIN: 10193489204667, Lot Number: 22IBS470; vvvvvv. PK, OPEN HEART-A&B, Item Number: DYNJ44026C, Case UDI/GTIN: 40193489433518, Unit UDI/GTIN: 10193489433517, Lot Number: 22IBN326,22IBN327; wwwwww. OPEN HEART PACK, Item Number: DYNJ44033, Case UDI/GTIN: 40888277079862, Unit UDI/GTIN: 10888277079861, Lot Number: 22JBI150,22HBY546; xxxxxx. PK, OPEN HEART-CABG, Item Number: DYNJ44067A, Case UDI/GTIN: 40193489757898, Unit UDI/GTIN: 10193489757897, Lot Number: 22JBU916; yyyyyy. PK, OPEN HEART, Item Number: DYNJ44090D, Case UDI/GTIN: 40195327133338, Unit UDI/GTIN: 10195327133337, Lot Number: 22IBN978; zzzzzz. CASTRO CABG-COMPONENT PACK, Item Number: DYNJ44857T, Case UDI/GTIN: 40195327221950, Unit UDI/GTIN: 10195327221959, Lot Number: 22JBD481; aaaaaaa. RE-ENTRY PACK, Item Number: DYNJ44890F, Case UDI/GTIN: 40195327127757, Unit UDI/GTIN: 10195327127756, Lot Number: 22JDA683; bbbbbbb. HEART PACK, Item Number: DYNJ45022B, Case UDI/GTIN: 40193489657938, Unit UDI/GTIN: 10193489657937, Lot Number: 22JBT974,22HBY537,22HBV710; ccccccc. OPEN HEART SUPPLY PACK, Item Number: DYNJ45025A, Case UDI/GTIN: 40889942609131, Unit UDI/GTIN: 10889942609130, Lot Number: 22JLA524,22ILA816; ddddddd. PK, OPEN HEART-CABG, Item Number: DYNJ45048C, Case UDI/GTIN: 40193489808880, Unit UDI/GTIN: 10193489808889, Lot Number: 22IMD722; eeeeeee. CABG PROCEDURE PACK, Item Number: DYNJ45060D, Case UDI/GTIN: 40889942613633, Unit UDI/GTIN: 10889942613632, Lot Number: 22JBM611; fffffff. CABG PACK, Item Number: DYNJ45073I, Case UDI/GTIN: 40195327044726, Unit UDI/GTIN: 10195327044725, Lot Number: 22IBO185; ggggggg. PK, OPEN HEART, Item Number: DYNJ45074C, Case UDI/GTIN: 40193489222679, Unit UDI/GTIN: 10193489222678, Lot Number: 22IBC441,22HBW259; hhhhhhh. VASCULAR GRAFT PACK, Item Number: DYNJ45076C, Case UDI/GTIN: 40889942947424, Unit UDI/GTIN: 10889942947423, Lot Number: 22HBI833; iiiiiii. PK, OPEN HEART, Item Number: DYNJ45179C, Case UDI/GTIN: 40193489204217, Unit UDI/GTIN: 10193489204216, Lot Number: 22IBL978,22HBI927; jjjjjjj. VASCULAR PACK, Item Number: DYNJ45422C, Case UDI/GTIN: 40195327040650, Unit UDI/GTIN: 10195327040659, Lot Number: 22JMF415; kkkkkkk. PK, OPEN HEART, Item Number: DYNJ46237D, Case UDI/GTIN: 40193489322843, Unit UDI/GTIN: 10193489322842, Lot Number: 22JBW004,22IBJ774,22HBR324; lllllll. OPEN HEART MINOR PACK, Item Number: DYNJ46425G, Case UDI/GTIN: 40193489833578, Unit UDI/GTIN: 10193489833577, Lot Number: 22JBW515,22IBT435,22IBH125,22IBH126,22IBH130; mmmmmmm. CABG PACK(CBSJE)227-LF, Item Number: DYNJ47486A, Case UDI/GTIN: 40889942106234, Unit UDI/GTIN: 10889942106233, Lot Number: 22IBQ923; nnnnnnn. OPEN HEART PACK (OHSJC)227, Item Number: DYNJ47493D, Case UDI/GTIN: 40889942324744, Unit UDI/GTIN: 10889942324743, Lot Number: 22IMF207,22IMF212; ooooooo. PACEMAKER PACK, Item Number: DYNJ47619B, Case UDI/GTIN: 40193489730976, Unit UDI/GTIN: 10193489730975, Lot Number: 22JBJ759; ppppppp. BR VASCULAR PACK, Item Number: DYNJ47628A, Case UDI/GTIN: 40888277843340, Unit UDI/GTIN: 10888277843349, Lot Number: 22JBG043; qqqqqqq. VBMC OPEN HEART PACK, Item Number: DYNJ47638A, Case UDI/GTIN: 40193489735377, Unit UDI/GTIN: 10193489735376, Lot Number: 22JBT976,22HBX785; rrrrrrr. PACEMAKER-LF, Item Number: DYNJ47644D, Case UDI/GTIN: 40193489952125, Unit UDI/GTIN: 10193489952124, Lot Number: 22IMH194; sssssss. OPEN HEART PACK-RFD-LF, Item Number: DYNJ47770O, Case UDI/GTIN: 40193489308304, Unit UDI/GTIN: 10193489308303, Lot Number: 22JBB013,22IBI370; ttttttt. PACEMAKER PACK, Item Number: DYNJ47772G, Case UDI/GTIN: 40193489463263, Unit UDI/GTIN: 10193489463262, Lot Number: 22HMD743; uuuuuuu. VASCULAR PACK-LF, Item Number: DYNJ48196C, Case UDI/GTIN: 40193489712460, Unit UDI/GTIN: 10193489712469, Lot Number: 22HBP970; vvvvvvv. CV VASCULAR PACK, Item Number: DYNJ48253J, Case UDI/GTIN: 40193489805735, Unit UDI/GTIN: 10193489805734, Lot Number: 22JMH939; wwwwwww. HEART A&B PACK, Item Number: DYNJ48313F, Case UDI/GTIN: 40193489840354, Unit UDI/GTIN: 10193489840353, Lot Number: 22JBI418,22HBW107; xxxxxxx. OPEN HEART PACK, Item Number: DYNJ49059, Case UDI/GTIN: 40888277815576, Unit UDI/GTIN: 10888277815575, Lot Number: 22HBJ896; yyyyyyy. HAVASU BASIC OPEN HEART PACK, Item Number: DYNJ49104C, Case UDI/GTIN: 40193489776554, Unit UDI/GTIN: 10193489776553, Lot Number: 22IMC796,22HMB847; zzzzzzz. VASCULAR PACK, Item Number: DYNJ49156, Case UDI/GTIN: 40888277819277, Unit UDI/GTIN: 10888277819276, Lot Number: 22HME394; aaaaaaaa. PK, EP LAB, Item Number: DYNJ49513C, Case UDI/GTIN: 40193489268301, Unit UDI/GTIN: 10193489268300, Lot Number: 22JMD840,22IME354,22IME355; bbbbbbbb. PACEMAKER PACK, Item Number: DYNJ49534A, Case UDI/GTIN: 40889942275688, Unit UDI/GTIN: 10889942275687, Lot Number: 22JBU805,22IBG083; cccccccc. CARDIOVASCULAR PACK LJ-LF, Item Number: DYNJ49635F, Case UDI/GTIN: 40195327191406, Unit UDI/GTIN: 10195327191405, Lot Number: 22IMI321,22IMH472,22IMD161; dddddddd. PACEMAKER PACK, Item Number: DYNJ50379A, Case UDI/GTIN: 40889942300922, Unit UDI/GTIN: 10889942300921, Lot Number: 22JBX697; eeeeeeee. CAROTID VASCULAR ENDARTERECTMY, Item Number: DYNJ50528M, Case UDI/GTIN: 40195327129690, Unit UDI/GTIN: 10195327129699, Lot Number: 22HBX666; ffffffff. MARQUETTE CV PACK, Item Number: DYNJ50987C, Case UDI/GTIN: 40193489499088, Unit UDI/GTIN: 10193489499087, Lot Number: 22HDB888; gggggggg. DR DANIELSON AC PACK, Item Number: DYNJ51038Q, Case UDI/GTIN: 40195327174072, Unit UDI/GTIN: 10195327174071, Lot Number: 22JBI155; hhhhhhhh. PACEMAKER INSERTION PACK, Item Number: DYNJ51097A, Case UDI/GTIN: 40193489985390, Unit UDI/GTIN: 10193489985399, Lot Number: 22HDC254; iiiiiiii. MAJOR VASCULAR PACK, Item Number: DYNJ51305B, Case UDI/GTIN: 40193489460972, Unit UDI/GTIN: 10193489460971, Lot Number: 22JMG823; jjjjjjjj. PACEMAKER PACK-LF, Item Number: DYNJ51844B, Case UDI/GTIN: 40889942615774, Unit UDI/GTIN: 10889942615773, Lot Number: 22JMA106; kkkkkkkk. MAJOR VASCULAR PACK-LF, Item Number: DYNJ52054A, Case UDI/GTIN: 40195327104567, Unit UDI/GTIN: 10195327104566, Lot Number: 22HBL905; llllllll. HEART PACK, Item Number: DYNJ52362G, Case UDI/GTIN: 40195327237739, Unit UDI/GTIN: 10195327237738, Lot Number: 22IBK723; mmmmmmmm. VALVE PACK, Item Number: DYNJ52363D, Case UDI/GTIN: 40195327183807, Unit UDI/GTIN: 10195327183806, Lot Number: 22JBD487,22IBS584; nnnnnnnn. PACEMAKER PACK, Item Number: DYNJ53636A, Case UDI/GTIN: 40193489292863, Unit UDI/GTIN: 10193489292862, Lot Number: 22IBQ560; oooooooo. CABG PACK, Item Number: DYNJ53827, Case UDI/GTIN: 40889942444015, Unit UDI/GTIN: 10889942444014, Lot Number: 22JBD306; pppppppp. VASCULAR PACK, Item Number: DYNJ53995G, Case UDI/GTIN: 40195327073764, Unit UDI/GTIN: 10195327073763, Lot Number: 22IBD708; qqqqqqqq. VASCULAR PACK-LF, Item Number: DYNJ54381G, Case UDI/GTIN: 40193489815444, Unit UDI/GTIN: 10193489815443, Lot Number: 22JMH270; rrrrrrrr. CABG INTRA OP SURGICOUNT PACK, Item Number: DYNJ55823G, Case UDI/GTIN: 40193489953498, Unit UDI/GTIN: 10193489953497, Lot Number: 22JBC268,22HBX703; ssssssss. PK, OPEN HEART, Item Number: DYNJ56089, Case UDI/GTIN: 40889942603344, Unit UDI/GTIN: 10889942603343, Lot Number: 22IBM871,22HBW951,22HMC219; tttttttt. PEDIATRIC OPEN HEART PACK, Item Number: DYNJ56796, Case UDI/GTIN: 40889942681458, Unit UDI/GTIN: 10889942681457, Lot Number: 22JMG835,22IMB362,22HMC357; uuuuuuuu. PCNL PACK-LF, Item Number: DYNJ56954B, Case UDI/GTIN: 40889942778158, Unit UDI/GTIN: 10889942778157, Lot Number: 22IMG593; vvvvvvvv. CAROTID PACK-LF, Item Number: DYNJ57646B, Case UDI/GTIN: 40193489828505, Unit UDI/GTIN: 10193489828504, Lot Number: 22IME979; wwwwwwww. ENSEMBLE VALVE-LF, Item Number: DYNJ58123B, Case UDI/GTIN: 40195327078721, Unit UDI/GTIN: 10195327078720, Lot Number: 22IBL147,22IBK251,22HBF572; xxxxxxxx. PONTAGE-LF, Item Number: DYNJ58124C, Case UDI/GTIN: 40195327078738, Unit UDI/GTIN: 10195327078737, Lot Number: 22HBH900; yyyyyyyy. MINOR CARDIAC PACK-LF, Item Number: DYNJ58381C, Case UDI/GTIN: 40193489230711, Unit UDI/GTIN: 10193489230710, Lot Number: 22JMC834,22JMC835,22HMC125; zzzzzzzz. FEMORAL A LINE PACK-LF, Item Number: DYNJ59102A, Case UDI/GTIN: 40195327040643, Unit UDI/GTIN: 10195327040642, Lot Number: 22IMD766; aaaaaaaaa. PACEMAKER PACK, Item Number: DYNJ59123, Case UDI/GTIN: 40889942937500, Unit UDI/GTIN: 10889942937509, Lot Number: 22HLB249; bbbbbbbbb. VASCULAR PACK, Item Number: DYNJ59361B, Case UDI/GTIN: 40195327000340, Unit UDI/GTIN: 10195327000349, Lot Number: 22JBI630,22IBM237; ccccccccc. OPEN HEART A&B PACK, Item Number: DYNJ59604A, Case UDI/GTIN: 40193489457927, Unit UDI/GTIN: 10193489457926, Lot Number: 22JBT640,22IBK862,22HBZ301; ddddddddd. PK, OPEN HEART, Item Number: DYNJ59695B, Case UDI/GTIN: 40193489791182, Unit UDI/GTIN: 10193489791181, Lot Number: 22JBU415,22IBJ783; eeeeeeeee. PACEMAKER PACK, Item Number: DYNJ60055, Case UDI/GTIN: 40888277794147, Unit UDI/GTIN: 10888277794146, Lot Number: 22JBK003,22HBY483; fffffffff. PK, OPEN HEART-FIRSTY/HANNA, Item Number: DYNJ63108A, Case UDI/GTIN: 40193489781381, Unit UDI/GTIN: 10193489781380, Lot Number: 22JMD080,22IMB793; ggggggggg. CABG ACCESSORIES, Item Number: DYNJ63134A, Case UDI/GTIN: 40193489432597, Unit UDI/GTIN: 10193489432596, Lot Number: 22IBC805; hhhhhhhhh. PEDS HEART MAJOR, Item Number: DYNJ63135, Case UDI/GTIN: 40193489721615, Unit UDI/GTIN: 10193489721614, Lot Number: 22IBD750; iiiiiiiii. HEART MAJOR, Item Number: DYNJ63136B, Case UDI/GTIN: 40193489833585, Unit UDI/GTIN: 10193489833584, Lot Number: 22JBX699,22IBT444; jjjjjjjjj. VASCULAR PACK, Item Number: DYNJ63182, Case UDI/GTIN: 40193489723404, Unit UDI/GTIN: 10193489723403, Lot Number: 22JBI165,22HBL764; kkkkkkkkk. NOLEN VALVE PACK, Item Number: DYNJ63767B, Case UDI/GTIN: 40193489266796, Unit UDI/GTIN: 10193489266795, Lot Number: 22JBI672; lllllllll. CV MINOR PK, Item Number: DYNJ64038, Case UDI/GTIN: 40193489782142, Unit UDI/GTIN: 10193489782141, Lot Number: 22IMI061,22HMD756; mmmmmmmmm. HEART CABG PK, Item Number: DYNJ64040C, Case UDI/GTIN: 40195327050215, Unit UDI/GTIN: 10195327050214, Lot Number: 22IMF685; nnnnnnnnn. NON CABG PK, Item Number: DYNJ64046B, Case UDI/GTIN: 40195327050208, Unit UDI/GTIN: 10195327050207, Lot Number: 22IMF875; ooooooooo. CVOR ENDOVASCULAR PACK, Item Number: DYNJ64506A, Case UDI/GTIN: 40193489971065, Unit UDI/GTIN: 10193489971064, Lot Number: 22JBN274,22IBS808; ppppppppp. VASCULAR, Item Number: DYNJ64767A, Case UDI/GTIN: 40193489456159, Unit UDI/GTIN: 10193489456158, Lot Number: 22IDA696; qqqqqqqqq. VASCULAR SHARED, Item Number: DYNJ64801B, Case UDI/GTIN: 40195327218127, Unit UDI/GTIN: 10195327218126, Lot Number: 22JDB419,22HDC153; rrrrrrrrr. CARDIAC PACK, Item Number: DYNJ65027B, Case UDI/GTIN: 40193489471992, Unit UDI/GTIN: 10193489471991, Lot Number: 22JBT419,22JBE649; sssssssss. PACEMAKER PACK, Item Number: DYNJ66006, Case UDI/GTIN: 40193489312585, Unit UDI/GTIN: 10193489312584, Lot Number: 22HBP090; ttttttttt. OPEN HEART ORANGE PARK PACK, Item Number: DYNJ66157, Case UDI/GTIN: 40193489319744, Unit UDI/GTIN: 10193489319743, Lot Number: 22JBO191; uuuuuuuuu. VASCULAR PACK, Item Number: DYNJ66577, Case UDI/GTIN: 40193489360968, Unit UDI/GTIN: 10193489360967, Lot Number: 22IBM137; vvvvvvvvv. VASCULAR PACK, Item Number: DYNJ66614, Case UDI/GTIN: 40193489366410, Unit UDI/GTIN: 10193489366419, Lot Number: 22IMF244; wwwwwwwww. VASCULAR PACK, Item Number: DYNJ67151A, Case UDI/GTIN: 40195327023813, Unit UDI/GTIN: 10195327023812, Lot Number: 22JBX719,22IBJ917,22HBX262,22
Other Recalls from MEDLINE INDUSTRIES, LP - Northfield
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2567-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2566-2025 | Class I | Medline medical convenience kits labeled as: ... | Jul 25, 2025 |
| Z-2479-2025 | Class II | Medline Kits containing BD SureStep Foley Tray ... | Jul 23, 2025 |
| Z-2460-2025 | Class I | Medline ReNewal Reprocessed St. Jude Medical Re... | Jul 14, 2025 |
| Z-2452-2025 | Class II | The Medline General Surgery Tray is customized ... | Jul 8, 2025 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.