Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the...
FDA Device Recall #Z-2299-2023 — Class II — May 15, 2023
Recall Summary
| Recall Number | Z-2299-2023 |
| Classification | Class II — Moderate risk |
| Date Initiated | May 15, 2023 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | MEDLINE INDUSTRIES, LP - Northfield |
| Location | Northfield, IL |
| Product Type | Devices |
| Quantity | 104,755 kits |
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. MULTI-LUMEN CVC BUNDLE KIT, Model Number: ECVC475; b. MULTI-LUMEN CVC INSERTION BUNDLE, Model Number: ECVC3900; c. MULTIMED 16G 1L 20CM CVC STOCK+BUNDLE US, Model Number: STCVC20US; d. MULTIMED 7F 2L 16CM STOCK + BUNDLE US, Model Number: STCVC21US; e. MULTIMED 7F 3L 16CM CVC BUNDLE, Model Number: ECVC6585A; f. MULTIMED 7F 3L 20CM PI, Model Number: ECVC7235A; g. MULTIMED 7FR 16CM CVC STK + BUNDLE-US, Model Number: STCVC03US; h. MULTIMED 7FR 3L 16CM CVC BUNDLE, Model Number: ECVC6655A; i. MULTIMED 7FR 3L 20CM CVC BUNDLE-US, Model Number: ECVC7935; j. MULTIMED 7FR 3L 20CM CVC STK + BUNDLE-US, Model Number: STCVC04US; k. MULTIMED 7FR, 20CM, 3L CVC BUNDLE, Model Number: ECVC7670; l. MULTIMED 8.5F 20CM QUAD CVC BUNDLE, Model Number: ECVC7090; m. MULTIMED 8.5FR 16CM QUAD CVC BUNDLE, Model Number: ECVC6930; n. MULTIMED 8.5FR 2L 16CM CVC STK+BUNDLE-US, Model Number: STCVC13US; o. NEURO CATH PACK (NCLUA)227-LF, Model Number: DYNJ47646D, DYNJ47646F, DYNJ47646G, DYNJ47646I; p. O.R. DOUBLE LUMEN INSERTION TRAY, Model Number: ECVC8010; q. OLEAN GENERAL CVC BUNDLE, Model Number: ECVC4615; r. OR ANGIO PACK, Model Number: DYNJ59184B; s. OR ANGIOGRAM, Model Number: DYNJ909267; t. OR ANGIOGRAPHY DRAPE, Model Number: DYNJ906297D; u. OR ANGIOGRAPHY PACK, Model Numbers: DYNJ67245A, DYNJ67245B; v. OR PERCUTANEOUS CATH PACK, Model Number: DYNJ63372A, DYNJ63372B, DYNJ63372C, DYNJ63372D; w. OR VANTEX 7FR 3L 16CM CVC, Model Number: ECVC6665; x. OR VASCULAR ANGIO PACK, Model Number: DYNJ69763, DYNJ69763A; y. PACK CARDIAC CATH, Model Number: DYNJ65481; z. PACK PERCUTANEOUS ANGIO CHRG, Model Number: DYNJ60112B; aa. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755G, DYNJ54755I; bb. PEDIATRIC CATH PACK-LF, Model Number: DYNJ0843244K; cc. PERCUTANEOUS ANGIO PACK-LF, Model Number: DYNJ57645C; dd. PERCUTANEOUS PACK, Model Number: DYNJ46035C, DYNJ46035D; ee. PERMA CATH PACK, Model Number: DYNJ62007A; ff. PI CVC BUNDLE, VANTEX 3L, 16CM, Model Number: ECVC3665; gg. PI CVC BUNDLE, VANTEX 3L, 20CM, Model Number: ECVC6190; hh. PI VANTEX 7FR 16CM 3L CVC BUNDLE-MAXPLUS, Model Number: ECVC4380; ii. PI VANTEX 7FR 16CM 3L CVC-MicroClave, Model Number: ECVC5655; jj. PI VANTEX 7FR 20CM 3L CVC-MicroClave, Model Number: ECVC5650; kk. PI VANTEX 8.5FR 16CM 4L CVC-MicroClave, Model Number: ECVC5660; ll. PI VANTEX 8.5FR 20CM 4L CVC-MicroClave, Model Number: ECVC5685; mm. PICC LINE PACK-LF, Model Number: DYNJ0275614F; nn. PK, RADIOLOGY, Model Number: DYNJ43894B; oo. PORT A CATH PACK, Model Number: DYNJ59307F; pp. PORT PACK, Model Number: DYNJ58162; qq. PORTACATH PACK, Model Number: DYNJ51240A; rr. QUAD LUMEN CVC BUNDLE 8.5F, 16CM, Model Number: ECVC3700; ss. QUAD LUMEN CVC BUNDLE, 8.5F, 20CM, Model Number: ECVC4995; tt. QUAD LUMEN CVC INSERTION BUNDLE, Model Numbers: ECVC5025, ECVC4135; uu. QUAD LUMEN KIT, Model Number: ECVC5820; vv. RADIOFREQUENCY ABLATION PACK, Model Number: DYNJ65913; ww. RADIOLOGY PACK, Model Numbers: DYNJ41190, DYNJ43894A, DYNJ44087A, DYNJ44524F, DYNJ52806C; xx. RADIOLOGY PACK 108402-LF, Model Number: DYNJVB1000; yy. RR-ADULT ECMO PACK, Model Number: DYNJ69742, DYNJ69742B; zz. SHEATH INTRODUCER BUNDLE, Model Number: ECVC2930, ECVC5835; aaa. SK-ANGIO TRAY-LF, Model Number: DYNJ82030; bbb. SK-INTERVENTIONAL TRAY-LF, Model Number: DYNJ82041; ccc. SPECIAL PROCEDURE CATH LAB PK, Model Number: DYNJ68729; ddd. SPECIAL PROCEDURE PACK, Model Number: DYNJ38314G; eee. SPECIAL PROCEDURE PACK-LF, Model Number: DYNJ0416535AA, DYNJ0416535W, DYNJ0458661C; fff. SPECIAL PROCEDURE PK-LF, Model Number: DYNJ0604508R; ggg. SPECIAL PROCEDURES, Model Number: DYNJ23288C; hhh. STANDARD ANGIO TRAY MV, Model Number: DYNJ67136A; iii. STD, AVA ,3XI ,3L 8.5F KIC, Model Number: ECVC7465A; jjj. STD, AVA, 3L, 9F, HF, KIC, Model Number: ECVC810
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution Pattern
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
Lot / Code Information
All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: ECVC475, UPC Number: 10653160333081. b. Model Number: ECVC3900, UPC Number: 10653160334828. c. Model Number: STCVC20US, UPC Number: 10653160339076. d. Model Number: STCVC21US, UPC Number: 10653160339045. e. Model Number: ECVC6585A, UPC Number: 10653160338826. f. Model Number: ECVC7235A, UPC Number: 10653160354550. g. Model Number: STCVC03US, UPC Number: 10653160339212. h. Model Number: ECVC6655A, UPC Number:10653160339267. i. Model Number: ECVC7935, UPC Number: 10653160353669. j. Model Number: STCVC04US, UPC Number: 10653160339199. k. Model Number: ECVC7670, UPC Number:10653160348054. l. Model Number: ECVC7090, UPC Number: 10653160339243. m. Model Number: ECVC6930, UPC Number:10653160339250. n. Model Number: STCVC13US, UPC Number: 10653160339137. o. Model Number: DYNJ47646D, UPC Number: 019348995047; Model Number: DYNJ47646F, UPC Number: 019532715551; Model Number: DYNJ47646G, UPC Number: 019532717502; Model Number: DYNJ47646I, UPC Number: 019532735712. p. Model Number: ECVC8010, UPC Number: 10653160356356. q. Model Number: ECVC4615, UPC Number: 10653160336075. r. Model Number: DYNJ59184B, UPC Number: 019348994910. s. Model Number: DYNJ909267, UPC Number: 019532731461. t. Model Number: DYNJ906297D, UPC Number: 019532714128. u. Model Number: DYNJ67245A, UPC Number: 019532702425; Model Number: DYNJ67245B, UPC Number: 019532729222. v. Model Number: DYNJ63372A, UPC Number: 019348929205; Model Number: DYNJ63372B, UPC Number: 019348947044; Model Number: DYNJ63372C, UPC Number: 019532708614; Model Number: DYNJ63372D, UPC Number: 019532727047. w. Model Number: ECVC6665, UPC Number: 10653160337843. x. Model Number: DYNJ69763, UPC Number: 019348997737; Model Number: DYNJ69763A, UPC Number: 019532733001. y. Model Number: DYNJ65481, UPC Number: 019348928046. z. Model Number: DYNJ60112B, UPC Number: 019532711884. aa. Model Number: DYNJ54755G, UPC Number: 019348998776; Model Number: DYNJ54755I, UPC Number: 019532702126. bb. Model Number: DYNJ0843244K, UPC Number: 019532728859. cc. Model Number: DYNJ57645C, UPC Number:019532728741. dd. Model Number: DYNJ46035C, UPC Number: 019348934095; Model Number: DYNJ46035D, UPC Number: 019348949364. ee. Model Number: DYNJ62007A, UPC Number: 019348987890. ff. Model Number: ECVC3665, UPC Number: 10653160336044. gg. Model Number: ECVC6190, UPC Number: 10653160337751. hh. Model Number: ECVC4380, UPC Number: 10653160338147. ii. Model Number: ECVC5655, UPC Number: 10653160337621. jj. Model Number: ECVC5650, UPC Number: 10653160336457. kk. Model Number: ECVC5660, UPC Number: 10653160337638. ll. Model Number: ECVC5685, UPC Number: 10653160337652. mm. Model Number: DYNJ0275614F, UPC Number: 088994217434. nn. Model Number: DYNJ43894B, UPC Number: 019348981048. oo. Model Number: DYNJ59307F, UPC Number: 019532705885. pp. Model Number: DYNJ58162, UPC Number: 088994282933. qq. Model Number: DYNJ51240A, UPC Number: 088994249352. rr. Model Number: ECVC3700, UPC Number: 10653160332886. ss. Model Number: ECVC4995, UPC Number: 10653160335283. tt. Model Number: ECVC5025, UPC Number: 10653160333142; Model Number: ECVC4135, UPC Number: 10653160335900. uu. Model Number: ECVC5820, UPC Number: 10653160338123. vv. Model Number: DYNJ65913, UPC Number: 019348930317. ww. Model Number: DYNJ41190, UPC Number: 088438989908; Model Number: DYNJ43894A, UPC Number: 088994213269; Model Number: DYNJ44087A, UPC Number: 088994256180; Model Number: DYNJ44524F, UPC Number: 019348946748; Model Number: DYNJ52806C, UPC Number: 019348929290. xx. Model Number: DYNJVB1000, UPC Number: 019348980099. yy. Model Number: DYNJ69742, UPC Number: 019348997490; Model Number: DYNJ69742B, UPC Number: 019532713688. zz. Model Number: ECVC2930, UPC Number: 10653160335368; Model Number: ECVC5835, UPC Number: 10653160333364. aaa. Model Number: DYNJ82030, UPC Number: 019532716237. bbb. Model Number: DYNJ82041, UPC Number: 019532716221. ccc. Model Number: DYNJ68729, UPC Number: 019348983654. ddd. Model Number: DYNJ38314G, UPC Number: 019348960334. eee. Model Number: DYNJ0416535AA, UPC Number: 019532735459; Model Number: DYNJ0416535W, UPC Number: 019348956435; Model Number: DYNJ0458661C, UPC Number: 088994255094. fff. Model Number: DYNJ0604508R, UPC Number: 019348982844. ggg. Model Number: DYNJ23288C, UPC Number: 019348995414. hhh. Model Number: DYNJ67136A, UPC Number: 019348993567. iii. Model Number: ECVC7465A, UPC Number: 10653160350088. jjj. Model Number: ECVC8100, UPC Number: 10653160357841. kkk. Model Number: DYNJ27613J, UPC Number: 019348956435; Model Number: DYNJ27613K, UPC Number: 019532713118. lll. Model Number: DYNJ80925, UPC Number: 019532708511. mmm. Model Number: DYNJ52425J, UPC Number: 019348994014. nnn. Model Number: DYNJ83251, UPC Number: 019532724865. ooo. Model Number: ECVC7310, UPC Number: 10653160345060; Model Number: ECVC7310A, UPC Number: 10653160352792. ppp. Model Number: ECVC2965, UPC Number: 10653160338611; Model Number: ECVC3155, UPC Number: 10653160334132; Model Number: ECVC5475, UPC Number: 10653160338116. qqq. Model Number: ECVC5015, UPC Number: 10653160338956. rrr. Model Number: ECVC3395, UPC Number: 10653160338635. sss. Model Number: ECVC5810, UPC Number: 10653160336419. ttt. Model Number: ECVC255, UPC Number: 10653160331735; Model Number: ECVC5200, UPC Number: 10653160336150. uuu. Model Number: ECVC825A, UPC Number: 10653160333548. vvv. Model Number: ECVC7180, UPC Number: 10653160343165. www. Model Number: ECVC7425, UPC Number: 10653160347699; Model Number: STCVC2040, UPC Number: 10653160336785; Model Number: STCVC2040A, UPC Number: 10653160345701. xxx. Model Number: ECVC7290, UPC Number: 10653160344933. yyy. Model Number: ECVC5355B, UPC Number: 10653160357742. zzz. Model Number: ECVC6020A, UPC Number: 10653160338413. aaaa. Model Number: ECVC1910, UPC Number:10653160334453; Model Number: ECVC5870A, UPC Number:10653160338383. bbbb. Model Number: ECVC6055A, UPC Number: 10653160335849. cccc. Model Number: ECVC6540, UPC Number: 10653160339397. dddd. Model Number: ECVC3735A, UPC Number: 10653160334798. eeee. Model Number: ECVC3355, UPC Number: 10653160333982; Model Number: ECVC3400, UPC Number: 10653160340591; Model Number: ECVC3460, UPC Number: 10653160332794; Model Number: ECVC3785, UPC Number: 10653160336006; Model Number: ECVC3810, UPC Number: 10653160336013; Model Number: ECVC4880, UPC Number: 10653160333111; Model Number: ECVC5020, UPC Number: 10653160334903; Model Number: ECVC5020A, UPC Number: 10653160358251; Model Number: ECVC5125, UPC Number: 10653160334934; Model Number: ECVC5270, UPC Number: 10653160336198; Model Number: ECVC6395, UPC Number: 10653160336372. ffff. Model Number: ECVC1490, UPC Number: 10653160332183; Model Number: ECVC1490A, UPC Number: 10653160359036; Model Number: ECVC1495, UPC Number: 10653160334569; Model Number: ECVC1495A, UPC Number: 10653160358794. gggg. Model Number: ECVC1710, UPC Number: 10653160332268. hhhh. Model Number: ECVC5815, UPC Number: 10653160336402. iiii. Model Number: DYNJ67990A, UPC Number: 019532726533. jjjj.Model Number: DYNJ41562F, UPC Number: 019348964108. kkkk. Model Number: DYNJ41562D, UPC Number: 019348958812. llll. Model Number: ECVC1655, UPC Number: 10653160254935. mmmm. Model Number: ECVC7170, UPC Number: 10653160333524. nnnn. Model Number: ECVC6680, UPC Number: 10653160337867; Model Number: ECVC6680A, UPC Number: 10653160337164. oooo. Model Number: ECVC6675, UPC Number: 10653160337850; Model Number: ECVC6675A, UPC Number: 10653160336617. pppp. Model Number: ECVC7970, UPC Number: 10653160353980. qqqq. Model Number: ECVC6815, UPC Number: 10653160335115. rrrr. Model Number: ECVC6840, UPC Number: 10653160336761. ssss. Model Number: ECVC6835, UPC Number: 10653160336778. tttt. Model Number: ECVC7485, UPC Number: 10653160354802. uuuu. Model Number: ECVC7615, UPC Number: 10653160348009; Model Number: ECVC7690, UPC Number: 10653160348153. vvvv. Model Number: ECVC6630, UPC Number: 10653160337492. wwww. Model Number: ECVC6690, UPC Number: 10653160336600. xxxx. Model Number: ECVC8135, UPC Number: 10653160358558; Model Number: ECVC8160, UPC Number: 10653160358404. yyyy. Model Number: ECVC7915, UPC Number: 10653160353355. zzzz. Model Number: ECVC6550, UPC Number: 10653160335276; Model Number: ECVC6595, UPC Number: 10653160337485; Model Number: ECVC7115B, UPC Number: 10653160350279; Model Number: ECVC7275, UPC Number: 10653160342700; Model Number: ECVC7275A, UPC Number: 10653160344292; Model Number: ECVC8015, UPC Number: 10653160355366. aaaaa. Model Number: ECVC7400, UPC Number: 10193489199956; Model Number: ECVC7960, UPC Number: 10653160353881; Model Number: ECVC8050, UPC Number: 10653160355601. bbbbb. Model Number: ECVC7945, UPC Number: 10653160353966. ccccc. Model Number: ECVC7625, UPC Number: 10653160356295. ddddd. Model Number: ECVC7895, UPC Number: 10653160355328. eeeee. Model Number: STCVC02US, UPC Number: 10653160336815; Model Number: STCVC02UST, UPC Number: 10653160358589. fffff. Model Number: ECVC7405, UPC Number: 10653160347132. ggggg. Model Number: ECVC7295, UPC Number: 10653160344650. hhhhh. Model Number: ECVC6765, UPC Number: 10653160336839. iiiii. Model Number: ECVC7495B, UPC Number: 10653160355748. jjjjj. Model Number: ECVC6505, UPC Number: 10653160336327; Model Number: ECVC7300, UPC Number: 10653160344698. kkkkk. Model Number: ECVC7560, UPC Number: 10653160347705; Model Number: ECVC7955, UPC Number: 10653160353867; Model Number: ECVC8020, UPC Number: 10653160355458; Model Number: ECVC8045, UPC Number: 10653160355595; Model Number: ECVC8085, UPC Number: 10653160356905. lllll. Model Number: ECVC8025, UPC Number: 10653160355434. mmmmm. Model Number: ECVC8040, UPC Number: 10653160355700. nnnnn. Model Number: ECVC7565, UPC Number: 10653160347682. ooooo. Model Number: ECVC7830A, UPC Number: 10653160355342. ppppp. Model Number: STCVC01US, UPC Number: 10653160336846; Model Number: STCVC01UST, UPC Number: 10653160358565. qqqqq. Model Number: ECVC7630, UPC Number: 10653160347750. rrrrr. Model Number: ECVC6050A, UPC Number: 10653160335894; Model Number: ECVC6670, UPC Number: 10653160336624; Model Number: ECVC7660, UPC Number: 10653160347804. sssss. Model Number: ECVC7385, UPC Number: 10653160346210; Model Number: ECVC7385A, UPC Number: 10653160347392; Model Number: ECVC7700, UPC Number: 10653160348375. ttttt. Model Number: ECVC5595, UPC Number: 10653160336495. uuuuu. Model Number: ECVC6800, UPC Number: 10653160335092. vvvvv. Model Number: ECVC7785, UPC Number: 10653160349365. wwwww. Model Number: ECVC6825A, UPC Number: 10653160336631. xxxxx. Model Number: ECVC7505A, UPC Number: 10653160352853. yyyyy. Model Number: ECVC7835A, UPC Number: 10653160355359. zzzzz. Model Number: ECVC8080, UPC Number: 10653160356899. aaaaaa. Model Number: STCVC06US, UPC Number: 10653160338314. bbbbbb. Model Number: ECVC1320, UPC Number: 10653160335795. cccccc. Model Number: ECVC6255, UPC Number: 10653160336525. dddddd. Model Number: ECVC6260, UPC Number: 10653160336488. eeeeee. Model Number: ECVC5080, UPC Number: 10653160337690. ffffff. Model Number: ECVC6920, UPC Number: 10653160336716; Model Number: ECVC7000, UPC Number: 10193489196399. gggggg. Model Number: ECVC6915, UPC Number: 10653160336723; Model Number: ECVC6975, UPC Number: 10653160336679. hhhhhh. Model Number: ECVC4105, UPC Number: 10653160334835. iiiiii. Model Number: ECVC6340A, UPC Number: 10653160355038. jjjjjj. Model Number: DYNJ0429121K, UPC Number: 019532706950. kkkkkk. Model Number: ECVC7330, UPC Number: 10653160345565.
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.