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Custom Sterile and Non-Sterile Procedural Kits containing… recallZ-2297-2023 · MEDLINE INDUSTRIES, LP - Northfield · initiated May 15, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from MEDLINE INDUSTRIES, LP - Northfield or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Nonconforming Material/Component

What the company is doing

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.

Recall details

Recall number
Z-2297-2023
Status
Open, Classified
Initiated by the company
May 15, 2023
Posted by the FDA
Aug 3, 2023
Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Quantity
97,677 kits
Product code
OES
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

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

Code information (models, lots, serial numbers)

Show the full code information (10k characters)

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.

Devices named in this recall

72 devices in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other products in the same recall event

The FDA groups related products into one recall event (event 92399).

Sources and updates

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