Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the...
FDA Device Recall #Z-2305-2023 — Class II — May 15, 2023
Recall Summary
| Recall Number | Z-2305-2023 |
| 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 | 146,157 kits |
Product Description
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A; c. ACCESS PICC PACK, Model Number: DYNJ40682B; d. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; e. AFCH CVC INSERTION, Model Number: DYNJ67534; f. ANGIOGRAM-DECH-LF, Model Number: DYNJ81725; g. ART LINE KIT ICH OR, Model Number: ART900; h. ARTERIAL LINE PACK, Model Number: DYNJ49235D; i. ARTERIOGRAM PACK, Model Number: DYNJ53095A, DYNJ55169G; j. AV FISTULA, Model Number: DYNJ64143A, DYNJ905219A, DYNJ906341C, DYNJ906945; k. AV FISTULA PACK, Model Number: DYNJ52093I, DYNJ62733, DYNJ66916, DYNJ67178; l. AV FISTULA PACK-LF, Model Number: DYNJ48428C, DYNJ64499A, DYNJ69167; m. AV SHUNT PACK-LF, Model Number: DYNJ0781844W; n. BARIATRIC KIT, Model Number: DYNJ901145F; o. BASIC VEIN PACK, Model Number: DYNJ69426; p. BCH VEIN ABLATION, Model Number: DYNJ69796; q. CATH LAB-VEIN PROCEDURES, Model Number: DYNJ60329A; r. CENTRAL LINE BUNDLE PACK-LF, Model Number: DYNJ22338K; s. CENTRAL LINE INSERTION KIT, Model Number: DYNJ52894A; t. CENTRAL LINE INSERTION PACK, Model Number: CVI4805; u. CENTRAL LINE KIT, Model Number: DYNDC2582A; v. CENTRAL LINE KIT UTMB, Model Number: DYNDC3061; w. CENTRAL LINE PACK, Model Number: DYNJ30087C, DYNJ48096B; x. CENTRAL LINE PACK-LF, Model Number: DYNJ0220136Q; y. CENTRAL LINE PLACEMENT PACK-LF, Model Number: DYNJ32358G; z. CENTRAL LINE PROCEDURE KIT, Model Number: DT22260; aa. CENTRAL LINE TRAY, Model Number: CVI4705; bb. CENTRAL VENOUS ACCESS PACK-LF, Model Number: DYNJ0214541O; cc. CVC/PICC INSERTION PACK EH-LF, Model Number: DYNJ40204A, DYNJ40204B; dd. CVL PACK, Model Number: DYNJ00281O; ee. CVR ENDOVENOUS PACK, Model Number: DYNJ80643; ff. DBD-AV FISTULA, Model Number: DYNJ904398D; gg. DBD-CENTRAL LINE TRAY, Model Number: DYNJ42902C; hh. DBD-LEE VEIN PACK, Model Number: DYNJ54906C; ii. DBD-PICC LINE PACK-LF, Model Number: DYNJ0373077O; jj. DBD-VARICOSE VEIN PACK, Model Number: DYNJ82884, DYNJ82885; kk. DBD-VASCULAR PACK-LF, Model Number: DYNJ56968; ll. DBD-VASCULAR VEIN PACK, Model Number: DYNJ69769; mm. DBD-VEIN PACK, Model Number: DYNJ82033; nn. DBD-VENCLOSE PROCEDURE PACK, Model Number: DYNJ80123; oo. DBD-VENOUS ACCESS PORT INSERTION, Model Number: DYNJ902602I; pp. DBD-VENOUS PACK, Model Number: DYNJ44243C, DYNJ80692; qq. DECLOT ACCESS, Model Number: DYNJ907279A, DYNJ907279B; rr. DEXMED ACCESS PACK, Model Number: DYNJ83148; ss. ENDOVENOUS ABLATION PACK, Model Number: DYNJ53435D; tt. ENS PICC LINE-HEJ-LF, Model Number: DYNJ67606; uu. ENSEMBLE POWER PICC-HEJ-LF, Model Number: DYNJ65827; vv. ER CENTRAL LINE KIT, Model Number: P155508D; ww. FISTULA SAVANNAH PACK, Model Number: DYNJ69943; xx. FISTULAGRAM PACK-LF, Model Number: DYNJ63213; yy. FNA TRAY, Model Number: DYNDH1123B; zz. GENERAL AV FISTULA, Model Number: DYNJ906011B; aaa. GROTH LASER VEIN CDS, Model Number: CDS984193Q; bbb. I.R. PICC PACK, Model Number: DYNDA2759; ccc. IR CENTRAL VENOUS ACCESS, Model Number: DYNJ43267G; ddd. IR PICC TRAY, Model Number: DYNDH1223; eee. JVL-PACK PICC, Model Number: DYNJ66062; fff. KIT MAJOR VASCULAR, Model Number: DYNJ907262A; ggg. KIT VEIN ABLATION, Model Number: DYNJ907381; hhh. LASER VEIN EC PACK, Model Number: DYNJ82951; iii. MAX BARRIER ART LINE KIT, Model Number: ART950; jjj. MHC AV FISTULA, Model Number: DYNJ903705G; kkk. MID HUDSON PICC LINE PACK, Model Number: DYNJ53618A; lll. MIDLINE INSERTION KIT, Model Number: DYNJ45178; mmm. MSB BEDSIDE TRAY, Model Number: DYNJ54670; nnn. MV-IR-PICC PACK-LF, Model Number: DYNJ41554C; ooo. NENTRAL LINE TRAY, Model Number: DYNJ42902D; ppp. NEONATAL PICC LINE TRAY, Model Number: DYNDC2120B; qqq. OPEN VASCULA
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: DYNJ65711, UPC Number: 019348928509. b. Model Number: DYNJ64141A, UPC Number: 019532727957. c. Model Number: DYNJ40682B, UPC Number: 088994226721. d. Model Number: DYNDA2482, UPC Number: 019348935160. e. Model Number: DYNJ67534, UPC Number: 019348940932. f. Model Number: DYNJ81725, UPC Number: 019532713675. g. Model Number: ART900, UPC Number: 065316034254. h. Model Number: DYNJ49235D, UPC Number: 019348989433. i. Model Number: DYNJ53095A, UPC Number: 019532714872; Model Number: DYNJ55169G, UPC Number: 019348996756. j. Model Number: DYNJ64143A, UPC Number: 019348928481; Model Number: DYNJ905219A, UPC Number: 019348928721; Model Number: DYNJ906341C, UPC Number: 019348981630; Model Number: DYNJ906945, UPC Number: 019348929927. k. Model Number: DYNJ52093I, UPC Number: 019348933747; Model Number: DYNJ62733, UPC Number: 019348968502; Model Number: DYNJ66916, UPC Number: 019348938765; Model Number: DYNJ67178, UPC Number: 019348941674. l. Model Number: DYNJ48428C, UPC Number: 019348970247; Model Number: DYNJ64499A, UPC Number: 019348986330; Model Number: DYNJ69167, UPC Number: 019348989918. m. Model Number: DYNJ0781844W, UPC Number: 019348922653. n. Model Number: DYNJ901145F, UPC Number: 019348932609. o. Model Number: DYNJ69426, UPC Number: 019348993939. p. Model Number: DYNJ69796, UPC Number: 019348997935. q. Model Number: DYNJ60329A, UPC Number: 019348997222. r. Model Number: DYNJ22338K, UPC Number: 019348936830. s. Model Number: DYNJ52894A, UPC Number: 088994243754. t. Model Number: CVI4805, UPC Number: 019532706871. u. Model Number: DYNDC2582A, UPC Number: 019348934939. v. Model Number: DYNDC3061, UPC Number: 019348949581. w. Model Number: DYNJ30087C, UPC Number: 088994275414; Model Number: DYNJ48096B, UPC Number: 088827793931. x. Model Number: DYNJ0220136Q, UPC Number: 019348982348. y. Model Number: DYNJ32358G, UPC Number: 088994252647. z. Model Number: DT22260, UPC Number: 065316032919. aa. Model Number: CVI4705, UPC Number: 019348983237. bb. Model Number: DYNJ0214541O, UPC Number: 019532708888. cc. Model Number: DYNJ40204A, UPC Number: 088994240964; Model Number: DYNJ40204B, UPC Number: 019532717845. dd. Model Number: DYNJ00281O, UPC Number: 019348996296. ee. Model Number: DYNJ80643, UPC Number: 019532705579. ff. Model Number: DYNJ904398D, UPC Number: 019348970132. gg. Model Number: DYNJ42902C, UPC Number: 019532708468. hh. Model Number: DYNJ54906C, UPC Number: 019532718876. ii. Model Number: DYNJ0373077O, UPC Number: 088994236495. jj. Model Number: DYNJ82884, UPC Number: 019532721599; Model Number: DYNJ82885, UPC Number: 019532721600. kk. Model Number: DYNJ56968, UPC Number: 088994269923. ll. Model Number: DYNJ69769, UPC Number: 019348997779. mm. Model Number: DYNJ82033, UPC Number: 019532716297. nn. Model Number: DYNJ80123, UPC Number: 019532700918. oo. Model Number: DYNJ902602I, UPC Number: 019348989256. pp. Model Number: DYNJ44243C, UPC Number: 019348970140; Model Number: DYNJ80692, UPC Number: 019532706554. qq. Model Number: DYNJ907279A, UPC Number: 019348990771; Model Number: DYNJ907279B, UPC Number: 019532711639. rr. Model Number: DYNJ83148, UPC Number: 019532723551. ss. Model Number: DYNJ53435D, UPC Number: 019532719644. tt. Model Number: DYNJ67606, UPC Number: 019348942167. uu. Model Number: DYNJ65827, UPC Number: 019348929849. vv. Model Number: P155508D, UPC Number: 019348989906. ww. Model Number: DYNJ69943, UPC Number: 019348999844. xx. Model Number: DYNJ63213, UPC Number: 019348972821. yy. Model Number: DYNDH1123B, UPC Number: 019348946555. zz. Model Number: DYNJ906011B, UPC Number: 019348941123. aaa. Model Number: CDS984193Q, UPC Number: 019532725508. bbb. Model Number: DYNDA2759, UPC Number: 019348948819. ccc. Model Number: DYNJ43267G, UPC Number: 019532728880. ddd. Model Number: DYNDH1223, UPC Number: 10889942567539. eee. Model Number: DYNJ66062, UPC Number: 019348931921. fff. Model Number: DYNJ907262A, UPC Number: 019348990913. ggg. Model Number: DYNJ907381, UPC Number: 019348990077. hhh. Model Number: DYNJ82951, UPC Number: 019532721897. iii. Model Number: ART950, UPC Number: 065316033022. jjj. Model Number: DYNJ903705G, UPC Number: 019348934550. kkk. Model Number: DYNJ53618A, UPC Number: 088994249249. lll. Model Number: DYNJ45178, UPC Number: 088827709574. mmm. Model Number: DYNJ54670, UPC Number: 088994249957. nnn. Model Number: DYNJ41554C, UPC Number: 088994281132. ooo. Model Number: DYNJ42902D, UPC Number: 019532717110. ppp. Model Number: DYNDC2120B, UPC Number: 019348936335. qqq. Model Number: DYNJ907858, UPC Number: 019348990935. rrr. Model Number: DYNJ81592, UPC Number: 019532712377. sss. Model Number: DYNJ81669, UPC Number: 019532713232; Model Number: DYNJ81669B, UPC Number: 019532725343. ttt. Model Number: CVI3650, UPC Number: 065316025639. uuu. Model Number: MNS13555, UPC Number: 065316099195. vvv. Model Number: DYNJ40990C, UPC Number: 088994202437. www. Model Number: DYNJ39039M, UPC Number: 019348989850. xxx. Model Number: GSS584Q, UPC Number: 019348994102. yyy. Model Number: CVI3830, UPC Number: 065316026994; Model Number: CVI4025A, UPC Number: 019348939605. zzz. Model Number: DYNJ60038A, UPC Number: 019532703833; Model Number: DYNJ61637, UPC Number: 019348958546. aaaa. Model Number: DYNJ40206A, UPC Number: 088827702610; Model Number: DYNJ40206B, UPC Number: 019532717644. bbbb. Model Number: DYNJ67415, UPC Number: 019348993088. cccc. Model Number: DYNJ51852B, UPC Number: 088994248122. dddd. Model Number: DYNJ70141MB, UPC Number: 088994272280. eeee. Model Number: DYNJ70152MB, UPC Number: 088994272282. ffff. Model Number: DYNJ55546C, UPC Number: 019348927672; Model Number: DYNJ55546D, UPC Number: 019532705652; Model Number: DYNJ64337, UPC Number: 019348980028. gggg. Model Number: DYNJ38868K, UPC Number: 019348956435; Model Number: DYNJ38868L, UPC Number: 019532722477. hhhh. Model Number: DYNJ34241, UPC Number: 088438933586. iiii. Model Number: DYNJ04592K, UPC Number: 019348921520; Model Number: DYNJ17017F, UPC Number: 019348956435; Model Number: DYNJ30233C, UPC Number: 019348938257; Model Number: DYNJ44089A, UPC Number: 088994249268; Model Number: DYNJ47037C, UPC Number: 019348961600; Model Number: DYNJ55170, UPC Number: 088994253218; Model Number: DYNJ55170A, UPC Number: 019348990860; Model Number: DYNJ55170B, UPC Number: 019348996757; Model Number: DYNJ55170C, UPC Number: 019532713535; Model Number: DYNJ64249A, UPC Number: 019348938136; Model Number: DYNJ65903, UPC Number: 019348930065. jjjj. Model Number: DYNJ0235859I, UPC Number: 019348956435; Model Number: DYNJ0235859J, UPC Number: 019532706927; Model Number: DYNJ0235859K, UPC Number: 019532724321; Model Number: DYNJ0678523M, UPC Number: 019348956435; Model Number: DYNJ0678523N, UPC Number: 019348999404; Model Number: DYNJ0855123N, UPC Number: 019532709488; Model Number: DYNJ21575G, UPC Number: 019348956435; Model Number: DYNJ21575I, UPC Number: 019532700967. kkkk. Model Number: DYNJ52688B, UPC Number: 019348945247; Model Number: DYNJ52688C, UPC Number: 019532730102; Model Number: DYNJ64725B, UPC Number: 019348945284. llll. Model Number: DYNJT2272J, UPC Number: 019348926312; Model Number: DYNJT2272K, UPC Number: 019532725067. mmmm. Model Number: DYNJ47717B, UPC Number: 019532735530. nnnn. Model Number: DYNJ35323, UPC Number: 019348956435. oooo. Model Number: DYNJ30566B, UPC Number: 088994237552; Model Number: DYNJ52255, UPC Number: 088994225370; Model Number: DYNJ60990A, UPC Number: 019348948445; Model Number: DYNJ60990B, UPC Number: 019348992170; Model Number: DYNJ65838, UPC Number: 019348930326; Model Number: DYNJ69088, UPC Number: 019348988361; Model Number: DYNJ69088A, UPC Number: 019348997524. pppp. Model Number: DYNJ0940720D, UPC Number: 088994255095; Model Number: DYNJ17086A, UPC Number: 088438906430; Model Number: DYNJ35000I, UPC Number: 019348926164; Model Number: DYNJ48120B, UPC Number: 088827789487; Model Number: DYNJ63162, UPC Number: 019348972089. qqqq. Model Number: DYNDC2373A, UPC Number: 088994249220. rrrr. Model Number: DYNJ33005D, UPC Number: 019348956435; Model Number: DYNJ33005F, UPC Number: 019348956435; Model Number: DYNJ35272, UPC Number: 088438942826; Model Number: DYNJ41648, UPC Number: 088438990917; Model Number: PICCNC0008, UPC Number: 019532722158. ssss. Model Number: DYNJ63590, UPC Number: 019348976918. tttt. Model Number: DYNJ31725A, UPC Number: 019348956435. uuuu. Model Number: DYNJ81726, UPC Number: 019532713677. vvvv. Model Number: DYNJ81284, UPC Number: 019532710571. wwww. Model Number: DYNJ35163C, UPC Number: 088994249468; Model Number: DYNJ56857A, UPC Number: 088994274727; Model Number: DYNJ56857C, UPC Number: 019348996758. xxxx. Model Number: DYNJ65775, UPC Number: 019348928982. yyyy. Model Number: DYNJ83534, UPC Number: 019532727671. zzzz. Model Number: DYNJ61894B, UPC Number: 019532700387.
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.