—#201771

Product

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

FDA product code: OFF — Central Venous Catheter Tray
Device class: Class 2
Medical specialty: Cardiovascular
Affected lot / code info: 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.

Why it was recalled

Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Medline notified customers beginning on 05/15/2023, via mail and email with letter. Customers with Medline Probe Cover Kits were instructed to check inventory for affected kits, destroy any affected kits, and complete and return the response form. Distributors were instructed to notify their customers and have them document and destroy affected kits. Customers with the non-sterile and sterile procedural kits were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits. Distributors were instructed to notify customers of the recall and have customers return any affected product for return to Medline. Medline identified additional units of Medline Probe Cover Kits and notified customers on 06/22/2023. Customers were instructed to quarantine kits, complete and return the response form and, once updated labels are received, over label and discard the affected ultrasound gel product within the kits.

Recalling firm

Firm: MEDLINE INDUSTRIES, LP Northfield
Address: 3 Lakes Dr, Northfield, Illinois 60093-2753

Distribution

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Timeline

Recall initiated: 2023-05-15
Posted by FDA: 2023-08-03
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #201771. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.