Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FI

Summary

The FDA issued a Class II for Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel by MEDLINE INDUSTRIES, LP - Northfield. Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications..

Details

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

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.

Quantity Affected: 146,157 kits

Reason for Recall

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

Type: Voluntary: Firm initiated

Recall Initiated: 2023-05-15

Company