Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. (13) S

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. (13) STC IVC FILTER/ANGIOGRAM, Model Number: DYNJ908249A; b. 16CM 3L 7FR CVC INSERTION BUNDLE, Model Numbers: ECVC7410A; c. 16CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC2205A; d. 16CM 7F CVC INSERTION TRAY, Model Number: ECVC8095; e. 16CM CVC BUNDLE W/MICROPUNCTURE KIT, Model Number: ECVC5010A; f. 16CM CVC INSERTION KIT, Model Number: ECVC6800A; g. 16CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2555; h. 16CM TRIPLE LUMEN CVC INSERT BUNDLE, Model Number: ECVC4125; i. 20CM 3L 7FR CVC INSERTION BUNDLE, Model Number: ECVC5135B; j. 20CM 3L CVC INSERTION TRAY, Model Number: ECVC7325; k. 20CM 7F 3L CVC MAX BARRIER INSERTION, Model Number: ECVC1970B; l. 20CM 7F CVC INSERTION TRAY, Model Number: ECVC4335; m. 20CM CVC TRIPLE LUMEN SAFETY BUNDLE, Model Number: ECVC7160; n. 20CM TRIPLE LUMEN 7FR INSERT BUNDLE, Model Number: ECVC2560; o. 20CM, 3L INSERT BUNDLE-CINCINNATI VA, Model Number: ECVC3505; p. 2L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC7075; q. 2L 8.5FR 16CM CVC INSERTION KIT, Model Number: ECVC8055; r. 3L 7FR 16 CM CVC INSERTION TRAY, Model Number: ECVC8165; s. 3L 7FR 16CM CVC INSERTION BUNDLE, Model Numbers: ECVC4635A, ECVC7040A, ECVC7430, ECVC7475, ECVC7605, ECVC7675, ECVC8130, STCVC2055US; t. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Number: ECVC7600; u. 3L 7FR 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC4640A, ECVC6490A, ECVC6845, ECVC7470; v. 3L 7FR 20CM CVC INSERTION TRAY, Model Number: ECVC6170; w. 7 FR 20 CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC3545; x. 7 FR 20CM CVC TRIPLE LUMEN BUNDLE, Model Number: ECVC2440B; y. 7F 20CM 3L CVC VANTEX BUNDLE, Model Number: ECVC7350; z. 7F, 16cm, 3L MAX BARRIER CVC BUNDLE, Model Number: ECVC5480; aa. 7F, 20CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC3475; bb. 7FR 16 CM TRIPLE LUMEN CVC INSERTION KIT, Model Number: ECVC2770; cc. 7FR 16CM TRIPLE LUMEN CVC BUNDLE, Model Number: ECVC6370; dd. 7FR 3L 16CM CVC INSERTION BUNDLE, Model Number: ECVC7910; ee. 7FR 3L 20CM CVC INSERTION BUNDLE, Model Numbers: ECVC7235, ECVC7905; ff. 7FR TRIPLE LUMEN CVC INSERTION BUNDLE, Model Number: ECVC2795; gg. 7FR,20CM,3L ANTIMICROBIAL CVC BUNDLE, Model Number: ECVC705; hh. 8.5F 16CM 2L CVC VANTEX BUNDLE, Model Number: ECVC7355; ii. 9F AVA HF RESUSCIT CVC BNDL, Model Number: ECVC6640; jj. ABLATION EP PACK, Model Number: DYNJ43851B; kk. ABLATION PACK, Model Number: DYNJ40629C; ll. ADULT CARDIAC CATH PACK, Model Numbers: DYNJ23455K, DYNJ23455L, DYNJ23455M, DYNJ23455N; mm. ANGIO, Model Numbers: DYNJ902507C, DYNJ905151B; nn. ANGIO CATH COMBINED PACK, Model Numbers: DYNJ43609O, DYNJ43609P, DYNJ43609R, DYNJ43609S; oo. ANGIO CATH LAB PACK-LF, Model Numbers: DYNJ0313233V, DYNJ0313233W, DYNJ0313233X; pp. ANGIO CATH PACK, Model Number: DYNJ52000B; qq. ANGIO DRAPE PACK, Model Numbers: DYNJ44320G, DYNJ44320I, DYNJ44320J; rr. ANGIO DRAPE PACK (ADLUG)642-LF, Model Numbers: DYNJ47665D, DYNJ47665F; ss. ANGIO HOLLAND PACK-LF, Model Numbers: DYNJ0037936C, DYNJ0037936D; tt. ANGIO PACK, Model Numbers: DYNJ42903C, DYNJ42903D, DYNJ43661C, DYNJ44642B, DYNJ58111D, DYNJ58111F, DYNJ69200, DYNJ69951; uu. ANGIO PACK-LF, Model Number: DYNJ0407399P; vv. ANGIO SAVANNAH PACK, Model Number: DYNJ69944; ww. ANGIO TRAY, Model Number: DYNJ23438M, DYNJ52121A, DYNJ69421, DYNJ69792, DYNJ82999, DYNJ82999A; xx. ANGIO/PICC PACK, Model Number: DYNJ36049A; yy. ANGIOGRAM, Model Number: DYNJ0149444N; zz. ANGIOGRAPHIC TRAY, Model Number: DYNJ67320A; aaa. ANGIOGRAPHY DRAPE PACK, Model Numbers: 00-400305R, DYNJ49621C, DYNJ63060B, DYNJ63684G, DYNJ68065B, DYNJ63684G; bbb. ANGIOGRAPHY PACK, Model Numbers: DYNJ44293F, DYNJ45059B, DYNJ55252C, DYNJ65190D, DYNJ65190F, DYNJ66476A, DYNJ67144A; ccc. ANGIOGRAPHY PACK-LF, Model Numbers: DYNJ0290716M, DYNJ0854485V; ddd. ANGIOPLASTY PACK, Model Number: DYNJ44700J; eee

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: DYNJ908249A, UPC Number: 019532724050. b. Model Number: ECVC7410A, UPC Number: 10653160353645. c. Model Number: ECVC2205A, UPC Number: 10653160357148. d. Model Number: ECVC8095, UPC Number: 10653160357759. e. Model Number: ECVC5010A, UPC Number: 10653160335290. f. Model Number: ECVC6800A, UPC Number: 10653160355694. g. Model Number: ECVC2555, UPC Number: 10653160336570. h. Model Number: ECVC4125, UPC Number: 10653160339502. i. Model Number: ECVC5135B, UPC Number: 10653160353652. j. Model Number: ECVC7325, UPC Number: 10653160345589. k. Model Number: ECVC1970B, UPC Number: 10653160357155. l. Model Number: ECVC4335, UPC Number: 10653160357285. m. Model Number: ECVC7160, UPC Number: 10653160335306. n. Model Number: ECVC2560, UPC Number: 10653160334286. o. Model Number: ECVC3505, UPC Number: 10653160334767. p. Model Number: ECVC7075, UPC Number: 10653160335122. q. Model Number: ECVC8055, UPC Number: 10653160355656. r. Model Number: ECVC8165, UPC Number: 10653160358749. s. Model Number: ECVC4635A, UPC Number: 10653160352112; Model Number: ECVC7040A, UPC Number: 10653160344414; Model Number: ECVC7430, UPC Number: 10653160346524; Model Number: ECVC7475, UPC Number: 10653160347569; Model Number: ECVC7605, UPC Number: 10653160347743; Model Number: ECVC7675, UPC Number: 10653160348122; Model Number: ECVC8005, UPC Number: 10653160355137; Model Number: ECVC8130, UPC Number: 10653160358343; Model Number: STCVC2055US, UPC Number: 10653160355564. t. Model Number: ECVC7600, UPC Number: 10653160347736. u. Model Number: ECVC4640A, UPC Number: 10653160352105; Model Number: ECVC6490A, UPC Number: 10653160344360; Model Number: ECVC6845, UPC Number: 10653160339366; Model Number: ECVC7470, UPC Number: 10653160347583. v. Model Number: ECVC6170, UPC Number: 10653160333395. w. Model Number: ECVC3545, UPC Number: 10653160334774. x. Model Number: ECVC2440B, UPC Number: 10653160358930. y. Model Number: ECVC7350, UPC Number: 10653160346265. z. Model Number: ECVC5480, UPC Number: 10653160339458. aa. Model Number: ECVC3475, UPC Number: 10653160334736. bb. Model Number: ECVC2770, UPC Number: 10653160332671. cc. Model Number: ECVC6370, UPC Number: 10653160333425. dd. Model Number: ECVC7910, UPC Number: 10653160357254. ee. Model Number: ECVC7235, UPC Number: 10653160341703; Model Number: ECVC7905, UPC Number: 10653160356912. ff. Model Number: ECVC2795, UPC Number: 10653160334200. gg. Model Number: ECVC705, UPC Number: 10653160331889. hh. Model Number: ECVC7355, UPC Number: 10653160346272. ii. Model Number: ECVC6640, UPC Number: 10653160333494. jj. Model Number: DYNJ43851B, UPC Number: 019532720032. kk. Model Number: DYNJ40629C, UPC Number: 019348999731. ll. Model Number: DYNJ23455K, UPC Number: 019348956435; Model Number: DYNJ23455L, UPC Number: 019348956435; Model Number: DYNJ23455M, UPC Number: 019348956435; Model Number: DYNJ23455N, UPC Number: 019532723775. mm. Model Number: DYNJ902507C, UPC Number: 019532713788; Model Number: DYNJ905151B, UPC Number: 019532721996. nn. Model Number: DYNJ43609O, UPC Number: 019348946871; Model Number: DYNJ43609P, UPC Number: 019348991453; Model Number: DYNJ43609R, UPC Number: 019532722878; Model Number: DYNJ43609S, UPC Number: 019532732298. oo. Model Number: DYNJ0313233V, UPC Number: 019348956435; Model Number: DYNJ0313233W, UPC Number: 019348956435; Model Number: DYNJ0313233X, UPC Number: 019532725098. pp. Model Number: DYNJ52000B, UPC Number: 019348938498. qq. Model Number: DYNJ44320G, UPC Number: 019348996630; Model Number: DYNJ44320I, UPC Number: 019532707035; Model Number: DYNJ44320J, UPC Number: 019532713235. rr. Model Number: DYNJ47665D, UPC Number: 019348995282; Model Number: DYNJ47665F, UPC Number: 019532735521. ss. Model Number: DYNJ0037936C, UPC Number: 019348956435; Model Number: DYNJ0037936D, UPC Number: 019532712953. tt. Model Number: DYNJ42903C, UPC Number: 019532707966; Model Number: DYNJ42903D, UPC Number: 019532717111; Model Number: DYNJ43661C, UPC Number: 019532710435; Model Number: DYNJ44642B, UPC Number: 019532701142; Model Number: DYNJ58111D, UPC Number: 019348993292; Model Number: DYNJ58111F, UPC Number: 019532722351; Model Number: DYNJ69200, UPC Number: 019348990681; Model Number: DYNJ69951, UPC Number: 019532700030. uu. Model Number: DYNJ0407399P, UPC Number: 019532733686. vv. Model Number: DYNJ69944, UPC Number: 019348999845. ww. Model Number: DYNJ23438M, UPC Number: 019348997060; Model Number: DYNJ52121A, UPC Number: 019532726009; Model Number: DYNJ69421, UPC Number: 019348993759; Model Number: DYNJ69792, UPC Number: 019348997928; Model Number: DYNJ82999, UPC Number: 019532722310; Model Number: DYNJ82999A, UPC Number: 019532731027. xx. Model Number: DYNJ36049A, UPC Number: 019532714720. yy. Model Number: DYNJ0149444N, UPC Number: 019348996671. zz. Model Number: DYNJ67320A, UPC Number: 019348993757. aaa. Model Number: 00-400305R, UPC Number: 019348994428; Model Number: DYNJ49621C, UPC Number: 019532700858; Model Number: DYNJ63060B, UPC Number: 019348991282; Model Number: DYNJ63684G, UPC Number: 019532703722; Model Number: DYNJ68065B, UPC Number: 019532701333. bbb. Model Number: DYNJ44293F, UPC Number: 019532726518; Model Number: DYNJ45059B, UPC Number: 088994213563; Model Number: DYNJ55252C, UPC Number: 019532726791; Model Number: DYNJ65190D, UPC Number: 019532706664; Model Number: DYNJ65190F, UPC Number: 019532709265; Model Number: DYNJ66476A, UPC Number: 019532705189; Model Number: DYNJ67144A, UPC Number: 019532717902. ccc. Model Number: DYNJ0290716M, UPC Number: 019532708886; Model Number: DYNJ0854485V, UPC Number: 019532709688. ddd. Model Number: DYNJ44700J, UPC Number: 019532727741. eee. Model Number: DYNJ43203G, UPC Number: 019348995291; Model Number: DYNJ64655B, UPC Number: 019348996101; Model Number: DYNJ64655C, UPC Number: 019532717289. fff. Model Number: DYNJ43261J, UPC Number: 019532728879; Model Number: DYNJ52774, UPC Number: 088994232247; Model Number: DYNJ53095, UPC Number: 088994237177; Model Number: DYNJ55169D, UPC Number: 019348972168; Model Number: DYNJ55169F, UPC Number: 019348984849. ggg. Model Number: DYNJ62733A, UPC Number: 019348997067. hhh. Model Number: ECVC7840A, UPC Number: 10653160355427. iii. Model Number: STCVC12US, UPC Number: 10653160311829. jjj. Model Number: ECVC3440, UPC Number: 10653160332770. kkk. Model Number: ECVC5640A, UPC Number: 10653160339977. lll. Model Number: ECVC7875, UPC Number: 10653160351535. mmm. Model Number: ECVC5860, UPC Number: 10653160341543. nnn. Model Number: ECVC5615, UPC Number: 10653160341512. ooo. Model Number: ECVC5665, UPC Number: 10653160341505. ppp. Model Number: ECVC4300, UPC Number: 10653160334873. qqq. Model Number: ECVC2600, UPC Number: 10653160334279. rrr. Model Number: ECVC3210, UPC Number: 10653160334071. sss. Model Number: ECVC7070B, UPC Number: 10653160346166. ttt. Model Number: DYNJV0177AF, UPC Number: 019348926312. uuu. Model Number: DYNJ41700A, UPC Number: 088994275695. vvv. Model Number: DYNJ907014A, UPC Number: 019348947402. www. Model Number: DYNJ38866D, UPC Number: 019348956435; Model Number: DYNJ38866F, UPC Number: 019348991486; Model Number: DYNJ67174A, UPC Number: 019532704680; Model Number: DYNJ67174B, UPC Number: 019532713108; Model Number: DYNJ82280, UPC Number: 019532718392; Model Number: DYNJ82296, UPC Number: 019532718420. xxx. Model Number: DYNJ0842644F, UPC Number: 019532728860; Model Number: DYNJ0855138P, UPC Number: 019348956435; Model Number: DYNJ0855138Q, UPC Number: 019532709484; Model Number: DYNJ42996C, UPC Number: 019348998843. yyy. Model Number: DYNJ45323F, UPC Number: 019532708236. zzz. Model Number: ECVC2660, UPC Number: 10653160338178. aaaa. Model Number: DYNJ64050A, UPC Number: 019348994382; Model Number: DYNJ63684G, UPC Number: 019532703722. bbbb. Model Number: DYNJ66182, UPC Number: 019348932098. cccc. Model Number: DYNJ33709F, UPC Number: 088994271392. dddd. Model Number: DYNJ33739G, UPC Number: 088994271393. eeee. Model Number: DYNJ55680A, UPC Number: 088994263978. ffff. Model Number: DYNJ68763, UPC Number: 019348983759; Model Number: DYNJ68763A, UPC Number: 019532726478. gggg. Model Number: DYNJ69864, UPC Number: 019348999048. hhhh. Model Number: DYNJ40926A, UPC Number: 019532713721; Model Number: DYNJ55455A, UPC Number: 019348938623; Model Number: DYNJ60763, UPC Number: 019348952796; Model Number: DYNJ66166A, UPC Number: 019348939599. iiii. Model Number: DYNJ67895, UPC Number: 019348945396. jjjj. Model Number: DYNJ57723B, UPC Number: 019348951627. kkkk. Model Number: DYNJ80269, UPC Number: 019532701780. llll. Model Number: DYNJ60329, UPC Number: 088994297098. mmmm. Model Number: DYNJ51338C, UPC Number: 019348924171; Model Number: DYNJ56547C, UPC Number: 019348987983; Model Number: DYNJ59632D, UPC Number: 019532703407; Model Number: DYNJ63181A, UPC Number: 019532704548; Model Number: DYNJ63181B, UPC Number: 019532712721; Model Number: DYNJ63181C, UPC Number: 019532724200; Model Number: DYNJ66473A, UPC Number: 019348991777; Model Number: DYNJ83089, UPC Number: 019532723083; Model Number: DYNJ83105, UPC Number: 019532723151. nnnn. Model Number: ECVC6970, UPC Number: 10653160336693. oooo. Model Number: ECVC360, UPC Number: 10653160332855. pppp. Model Number: ECVC3285, UPC Number: 10653160336105. qqqq. Model Number: ECVC2745, UPC Number: 10653160334224. rrrr. Model Number: ECVC2750, UPC Number: 10653160334217. ssss. Model Number: ECVC1140A, UPC Number: 10653160331964. tttt. Model Number: ECVC2300, UPC Number: 10653160334330. uuuu. Model Number: ECVC2305, UPC Number: 10653160332473. vvvv. Model Number: ECVC1345A, UPC Number: 10653160334606. wwww. Model Number: ECVC1725, UPC Number: 10653160334507. xxxx. Model Number: DYNJ81316, UPC Number: 019532710379. yyyy. Model Number: ECVC5530A, UPC Number: 10653160345596. zzzz. Model Number: DYNJ61082C, UPC Number: 019532711141; Model Number: DYNJ61082D, UPC Number: 019532726199. aaaaa. Model Number: DYNJ0378596I, UPC Number: 10195327188818; Model Number: DYNJ0378596J, UPC Number: 10195327310608.

Quantity Affected: 97,677 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