MEDLINE INDUSTRIES, LP - Northfield: 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

Recall number

Z-2297-2023

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

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

Status

Open, Classified

Initiated

2023-05-15

Posted

2023-08-03

Terminated

not on file

Reason

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

Root cause

Nonconforming Material/Component

Action

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.

Quantity

97,677 kits

Distribution

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

Lot, serial or model codes

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.

510(k) numbers

not on file

PMA numbers

not on file

Product code

OES

Firm FEI

1417592

Firm city

Northfield

Firm state

IL

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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