Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the...
FDA Device Recall #Z-2319-2023 — Class II — May 15, 2023
Recall Summary
| Recall Number | Z-2319-2023 |
| 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 | 83,541 kits |
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC4740; b. A V GRAFT, Model Number: DYNJ36212C; c. AAA, Model Number: DYNJ905651, DYNJ905651A, DYNJ905651B; d. AAA PACK, Model Number: DYNJ44918C; e. AAA PACK - TEAM 3, Model Number: DYNJ44847G; f. ABLATION PACK, Model Number: DYNJ62540, DYNJ64068; g. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658A; h. ACCESS KIT, Model Number: DYNDH1159A; i. ACCESS PACK, Model Number: DYNJ69017; j. ACCESSORY KIT, Model Number: DYNJ901348D; k. ADULT CORONARY PACK, Model Number: DYNJV0275F; l. ADULT CVC MAX BARRIER KIT-LF, Model Number: DYNJ38714B; m. ALL PURPOSE TRAY FOAKS, Model Number: DYNJ63576, DYNJ63576A; n. AMINO KIT; Model Number: DYNDH1649; o. AMNIOCENTESIS TRAY, Model Number: DYNDH1420; p. ANGIO STANDARD PACK-LF, Model Number: DYNJ0370436Q; q. ANGIO TRAY, Model Number: DYNJ23438J; r. ANGIOGRAM PACK, Model Number: DYNJ47004B; s. ANGIOGRAM TRAY, Model Number: DYNJ33638I; t. ANGIO-VASCULAR, Model Number: DYNJ24272B; u. ARTERIAL PACK, Model Number: DYNJ51340D; v. ARTERIO-VENOUS CDS, Model Number: CDS984186C; w. ASPIRATION TRAY, Model Number: DYNDH1467; x. ASPIRE EXACT TRAY, Model Number: DYNJRA1716, DYNJRA1716A; y. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299L; z. BASIC PACK, Model Number: DYNJ37460A, DYNJ42691, DYNJ52122B, DYNJ52171, DYNJ55456, DYNJ55457, DYNJ81343; aa. BASIC PROCEDURE PACK, Model Number: DYNJ53122B; bb. BASIC VEIN PACK, Model Number: DYNJ58650; cc. BEDSIDE PROCEDURE PREP KIT, Model Number: MNS7695A; dd. BGMC LIVER TRANSPLANT, Model Number: DYNJ9664651D; ee. BIOPSY TRAY, Model Number: DYNDH1340; ff. BLOCK KIT, Model Number: DYNJRA1145; gg. BLOCK SUPPLIES NDL CNTR, Model Number: DYNJRA1755; hh. BREAST ULTRASOUND PROCEDURE TR, Model Number: DYNDL1596A; ii. BUNDLE KIT, Model Number: DYNJ49737B, DYNJ49737C; jj. C V MAJOR PACK, Model Number: DYNJ64861; kk. CABG UNIVERSITY HOSP PACK-LF, Model Number: DYNJ0375705L; ll. CAROTID ENDARTERECTOMY, Model Number: DYNJ905640; mm. CHEST TUBE INSERTION TRAY, Model Number: TRICHT1120; nn. CHP TRANSPLANT CDS, Model Number: CDS983082I, CDS983082J; oo. CLINIC PACK, Model Number: DYNJRA1578; pp. CLOSURE CDS, Model Number: CDS983704G, CDS983704I; qq. CLOSURE FAST PACK UNIV, Model Number: DYNJ53482A; rr. CLOSURE PACK, Model Number: DYNJ54437A, DYNJ54437C, DYNJ57514, DYNJ60804; ss. CLOSURE PACK-LF, Model Number: DYNJ0807503M; tt. CLOSURE PROCEDURE, Model Number: DYNJ59206; uu. CLOSURE PROCEDURE PACK, Model Number: DYNJ66741; vv. CLOSURE PROCEDURE PKSJO-LF, Model Number: DYNJ35409F; ww. CLOT RETRIEVAL PACK, Model Number: DYNJ56140B; xx. CLOVIS MINOR IR PROCEDURE-LF, Model Number: DYNJ61067; yy. COMMANDO PACK MSH-LF, Model Number: DYNJ48525D; zz. CONTINUOUS BLOCK, Model Number: DYNJRA0960B; aaa. COPS PROCEDURE PACK-LF, Model Number: DYNJ68923A; bbb. CRMC MINOR IR PROCEDURE PK-LF, Model Number: DYNJ61099, DYNJ61099A; ccc. CV AAA PACK W AUX, Model Number: DYNJ65710; ddd. CV ACCESS PACK WRO-LF, Model Number: DYNJ41875B; eee. CV CDS, Model Number: CDS985395C; fff. CV MINOR CDS, Model Number: CDS984100T; ggg. CV PACK, Model Number: DYNJ45074B; hhh. CVC PACK, Model Number: DYNJ44010; iii. CVL PACK, Model Number: DYNJ00281N; jjj. CVOR CDS-LF, Model Number: CDS840198V; kkk. CYSTO PACK SMGH-LF, Model Number: DYNJ41915A; lll. DAVIES PHALLOPLASTY PACK, Model Number: DYNJ52185F; mmm. DAVINCI, Model Number: DYNJ906543A; nnn. DBD-BASIC PACK, Model Number: DYNJ55458; ooo. DBD-BIOPSY PACK-LF, Model Number: DYNJ0747885F; ppp. DBD-DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069M; qqq. DBD-ECMO MODULE PACK, Model Number: DYNJ55669F; rrr. DBD-EVLA PACK, Model Number: DYNJ6
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: ECVC4740, UPC Number: 10653160335214. b. Model Number: DYNJ36212C, UPC Number: 088994288566. c. Model Number: DYNJ905651, UPC Number: 088827778831; Model Number: DYNJ905651A, UPC Number: 019348968651; Model Number: DYNJ905651B, UPC Number: 019348992506. d. Model Number: DYNJ44918C, UPC Number: 019348976679. e. Model Number: DYNJ44847G, UPC Number: 019348962983. f. Model Number: DYNJ62540, UPC Number: 019348966647; Model Number: DYNJ64068, UPC Number: 019348978313. g. Model Number: DYNJ53658A, UPC Number: 088994268440. h. Model Number: DYNDH1159A, UPC Number: 088994288165. i. Model Number: DYNJ69017, UPC Number: 019348987815. j. Model Number: DYNJ901348D, UPC Number: 019348959468. k. Model Number: DYNJV0275F, UPC Number: 019348926312. l. Model Number: DYNJ38714B, UPC Number: 088994260193. m. Model Number: DYNJ63576, UPC Number: 019348976954; Model Number: DYNJ63576A, UPC Number: 019348942925. n. Model Number: DYNDH1649, UPC Number: 019348994436. o. Model Number: DYNDH1420, UPC Number: 019348936044. p. Model Number: DYNJ0370436Q, UPC Number: 088827777928. q. Model Number: DYNJ23438J, UPC Number: 019348956435. r. Model Number: DYNJ47004B, UPC Number: 088827775429. s. Model Number: DYNJ33638I, UPC Number: 019348956435. t. Model Number: DYNJ24272B, UPC Number: 019348956435. u. Model Number: DYNJ51340D, UPC Number: 019348956981. v. Model Number: CDS984186C, UPC Number: 088994295750. w. Model Number: DYNDH1467, UPC Number: 019348943966. x. Model Number: DYNJRA1716, UPC Number: 019348926312; Model Number: DYNJRA1716A, UPC Number: 019348989641. y. Model Number: DYNJC9299L, UPC Number: 019348926312. z. Model Number: DYNJ37460A, UPC Number: 088827756043; Model Number: DYNJ42691, UPC Number: 088827700350; Model Number: DYNJ52122B, UPC Number: 019348993530; Model Number: DYNJ52171, UPC Number: 088994224347; Model Number: DYNJ55456, UPC Number: 088994254844; Model Number: DYNJ55457, UPC Number: 088994254846; Model Number: DYNJ81343, UPC Number: 019532711306. aa. Model Number: DYNJ53122B, UPC Number: 019348932122. bb. Model Number: DYNJ58650, UPC Number: 088994287665. cc. Model Number: MNS7695A, UPC Number: 065316034345. dd. Model Number: DYNJ9664651D, UPC Number: 019348939642. ee. Model Number: DYNDH1340, UPC Number: 088994289450. ff. Model Number: DYNJRA1145, UPC Number: 088994292854. gg. Model Number: DYNJRA1755, UPC Number: 019348984284. hh. Model Number: DYNDL1596A, UPC Number: 088438992650. ii. Model Number: DYNJ49737B, UPC Number: 019348939440; Model Number: DYNJ49737C, UPC Number: 019532723588. jj. Model Number: DYNJ64861, UPC Number: 019348922377. kk. Model Number: DYNJ0375705L, UPC Number: 019348954413. ll. Model Number: DYNJ905640, UPC Number: 019348952767. mm. Model Number: TRICHT1120, UPC Number: 065316031829. nn. Model Number: CDS983082I, UPC Number: 088994277286; Model Number: CDS983082J, UPC Number: 019348967451. oo. Model Number: DYNJRA1578, UPC Number: 019348927278. pp. Model Number: CDS983704G, UPC Number: 088994280844; Model Number: CDS983704I, UPC Number: 019348985455. qq. Model Number: DYNJ53482A, UPC Number: 088994291731. rr. Model Number: DYNJ54437A, UPC Number: 088994256796; Model Number: DYNJ54437C, UPC Number: 019348924397; Model Number: DYNJ57514, UPC Number: 088994274784; Model Number: DYNJ60804, UPC Number: 019348953278. ss. Model Number: DYNJ0807503M, UPC Number: 088994209173. tt. Model Number: DYNJ59206, UPC Number: 088827776557. uu. Model Number: DYNJ66741, UPC Number: 019348937494. vv. Model Number: DYNJ35409F, UPC Number: 088827777124. ww. Model Number: DYNJ56140B, UPC Number: 019348954767. xx. Model Number: DYNJ61067, UPC Number: 019348954222. yy. Model Number: DYNJ48525D, UPC Number: 019348975077. zz. Model Number: DYNJRA0960B, UPC Number: 019348926312. aaa. Model Number: DYNJ68923A, UPC Number: 019532707079. bbb. Model Number: DYNJ61099, UPC Number: 019348954424; Model Number: DYNJ61099A, UPC Number: 019348946396. ccc. Model Number: DYNJ65710, UPC Number: 019348928508. ddd. Model Number: DYNJ41875B, UPC Number: 019348956307. eee. Model Number: CDS985395C, UPC Number: 088994286348. fff. Model Number: CDS984100T, UPC Number: 019348939994. ggg. Model Number: DYNJ45074B, UPC Number: 088994284064. hhh. Model Number: DYNJ44010, UPC Number: 088827707945. iii. Model Number: DYNJ00281N, UPC Number: 019348956435. jjj. Model Number: CDS840198V, UPC Number: 088994295567. kkk. Model Number: DYNJ41915A, UPC Number: 088827756881. lll. Model Number: DYNJ52185F, UPC Number: 019348936871. mmm. Model Number: DYNJ906543A, UPC Number: 019348981803. nnn. Model Number: DYNJ55458, UPC Number: 088994254845. ooo. Model Number: DYNJ0747885F, UPC Number: 019348956435. ppp. Model Number: DYNJ0426069M, UPC Number: 019532720575. qqq. Model Number: DYNJ55669F, UPC Number: 019532731371. rrr. Model Number: DYNJ66258A, UPC Number: 019532719423. sss. Model Number: DYNJ66620A, UPC Number: 019348991424. ttt. Model Number: CDS984379D, UPC Number: 088994272434. uuu. Model Number: DYNJ0604540Q, UPC Number: 019348983968. vvv. Model Number: DYNJ38563O, UPC Number: 019348925174. www. Model Number: DYNJ905936B, UPC Number: 019348942281. xxx. Model Number: DYNJ906902A, UPC Number: 019348997120. yyy. Model Number: DYNJ900337A, UPC Number: 088994219386. zzz. Model Number: DYNJ58160, UPC Number: 088994282864. aaaa. Model Number: DYNDA2769, UPC Number: 019348945716. bbbb. Model Number: DYNJ68923, UPC Number: 019348985856. cccc. Model Number: CDS984329J, UPC Number: 088994286535. dddd. Model Number: CDS984327I, UPC Number: 088994286537. eeee. Model Number: DYNJ33546K, UPC Number: 019348991717. ffff. Model Number: DYNJ908752, UPC Number: 019532717136. gggg. Model Number: DYNJ53845A, UPC Number: 088994253675. hhhh. Model Number: DYNJ68959, UPC Number: 019348986686. iiii. Model Number: DYNJ48454, UPC Number: 088827759528. jjjj. Model Number: DYNJ60128A, UPC Number: 019348954451. kkkk. Model Number: DYNJ907279, UPC Number: 019348938641. llll. Model Number: DYNJ31934D, UPC Number: 019532707150. mmmm. Model Number: DYNDA2011B, UPC Number: 019348953302. nnnn. Model Number: DYNJ59377, UPC Number: 088827773629. oooo. Model Number: DYNJRA0585, UPC Number: 088827758069. pppp. Model Number: DYNJ83438, UPC Number: 019532726659. qqqq. Model Number: DYNJ35457B, UPC Number: 019348956435. rrrr. Model Number: DYNJ905702B, UPC Number: 019348958721. ssss. Model Number: DYNJ66867, UPC Number: 019348939016. tttt. Model Number: DYNJ60669A, UPC Number: 019348920588; Model Number: DYNJ60669B, UPC Number: 019348987734; Model Number: DYNJ63156A, UPC Number: 019348985231; Model Number: DYNJ64964A, UPC Number: 019348935382. uuuu. Model Number: DYNJ82575, UPC Number: 019532719811. vvvv. Model Number: DYNJ0426069M, UPC Number: 019532720575. wwww. Model Number: DYNJRA1226A, UPC Number: 019348956964. xxxx. Model Number: DYNJ66283A, UPC Number: 019348940904. yyyy. Model Number: DYNJ907552, UPC Number: 019348949583. zzzz. Model Number: DYNJ0351069, UPC Number: 088994205905.
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.