MEDLINE INDUSTRIES, LP - Northfield: Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O; e. BARIATRIC PACK, Model Number: DYNJ24459P; f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242; g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942; h. DBD-FETOSCOPIC, Model Number: DYNJ905761A; i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B; j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A; k. DIEP, Model Number: DYNJ901296B; l. DIEP FLAP, Model Number: DYNJ66867A; m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N; n. ECMO PACK, Model Number: DYNJ82517; o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B; p. ENDOVASCULAR, Model Number: DYNJ63343G; q. EVLT SURGICAL PACK, Model Number: DYNJ48520; r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q; s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C; t. FLAP HARVEST PACK, Model Number: DYNJ58575B; u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O; v. FREE FLAP, Model Number: DYNJ905634B; w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290; x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K; y. FREE FLAP BASIN PACK, Model Number: DYNJ69914; z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A; aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B; bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K; cc. GENERAL ANGIO PACK, Model Number: DYNJ57760; dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M; ee. HILLCREST PCNL PACK, Model Number: DYNJ69204; ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B; gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; hh. LAP CHOLE PACK, Model Number: DYNJ41208D; ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B; jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A; kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A; ll. MINOR, Model Number: DYNJ906915; mm. MINOR CV, Model Number: DYNJ69898A; nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A; pp. PCNL PACK, Model Number: DYNJ0569950Q; qq. PLANO DIEP PACK, Model Number: DYNJ81751; rr. PORT PACK, Model Number: DYNJ61747C; ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C; tt. PV MINOR PACK, Model Number: DYNJ63879D; uu. RF PACK, Model Number: DYNJ52505A; vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C; ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F; xx. ROBOTIC-LF, Model Number: DYNJ904254F; yy. ROBOTICS GYN, Model Number: DYNJ905824D; zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A; aaa. TAA AAA, Model Number: DYNJ63339C; bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B; ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;

Recall number

Z-2312-2023

Recalling firm

MEDLINE INDUSTRIES, LP - Northfield

Product

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYNJ81410B; c. BARIATRIC KIT, Model Number: DYNJ901145G; d. BARIATRIC LAPAROSCOPY R-Y PACK, Model Number: DYNJC9299M, DYNJC9299O; e. BARIATRIC PACK, Model Number: DYNJ24459P; f. CENTRAL CATHETER INSERTION PK, Model Number: DYNJ36242; g. CYSTO PACK, Model Number: DYNJ60667C, DYNJ60667D, DYNJ60667F, DYNJ83942; h. DBD-FETOSCOPIC, Model Number: DYNJ905761A; i. DBD-FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447B; j. DBD-HILLCREST PCNL PACK, Model Number: DYNJ69204A; k. DIEP, Model Number: DYNJ901296B; l. DIEP FLAP, Model Number: DYNJ66867A; m. DONOR FREE FLAP PACK-LF, Model Number: DYNJ0426069N; n. ECMO PACK, Model Number: DYNJ82517; o. ENDOLUMINAL ACCESSORY PACK, Model Number: DYNJ44210B; p. ENDOVASCULAR, Model Number: DYNJ63343G; q. EVLT SURGICAL PACK, Model Number: DYNJ48520; r. FETAL SURGERY CDS-LF, Model Number: CDS840214Q; s. FLAP, Model Number: DYNJ907076A, DYNJ907076B, DYNJ907076C; t. FLAP HARVEST PACK, Model Number: DYNJ58575B; u. FLAP RECONSTRUCTION PACK-LF, Model Number: DYNJ0378388O; v. FREE FLAP, Model Number: DYNJ905634B; w. FREE FLAP ACCESSORIES, Model Number: DYNJ80290; x. FREE FLAP BASIC SET-UP PK, Model Number: DYNJ0991320K; y. FREE FLAP BASIN PACK, Model Number: DYNJ69914; z. FREE FLAP NO DRAPE PACK NTX, Model Number: DYNJ68447, DYNJ68447A; aa. FREE FLAP PACK CTX, Model Number: DYNJ68380, DYNJ68380A, DYNJ68380B; bb. FREE FLAP PACK-LF, Model Number: DYNJ0049595C, DYNJ20495K; cc. GENERAL ANGIO PACK, Model Number: DYNJ57760; dd. GU DAVINCI CDS, Model Number: CDS982779L, CDS982779M; ee. HILLCREST PCNL PACK, Model Number: DYNJ69204; ff. KIT FREE FLAP MOSES, Model Number: DYNJ905366A, DYNJ905366B; gg. KIT STC PLASTIC FREE FLAP, Model Number: DYKMBNDL54A; hh. LAP CHOLE PACK, Model Number: DYNJ41208D; ii. LAPAROSCOPIC COLORECTAL PACK, Model Number: DYNJ80172, DYNJ80172A, DYNJ80172B; jj. MAIN ESOPHAGECTOMY PACK, Model Number: DYNJ68172A; kk. MAXIMAL BARRIER BEDSIDE PACK, Model Number: DYNJ53059A; ll. MINOR, Model Number: DYNJ906915; mm. MINOR CV, Model Number: DYNJ69898A; nn. MINOR PROCEDURE TRAY, Model Number: DYNDA2418; oo. PACK FREE FLAP CHRG, Model Number: DYNJ60242A; pp. PCNL PACK, Model Number: DYNJ0569950Q; qq. PLANO DIEP PACK, Model Number: DYNJ81751; rr. PORT PACK, Model Number: DYNJ61747C; ss. PROCEDURE PACK DR BILIMORI, Model Number: DYNJ908046C; tt. PV MINOR PACK, Model Number: DYNJ63879D; uu. RF PACK, Model Number: DYNJ52505A; vv. ROBOTIC, Model Number: DYNJ904219G, DYNJ904343C; ww. ROBOTIC PACK-LF, Model Number: DYNJ904250F; xx. ROBOTIC-LF, Model Number: DYNJ904254F; yy. ROBOTICS GYN, Model Number: DYNJ905824D; zz. SINGLE SHOT BLOCK, Model Number: DYNJRA0961A; aaa. TAA AAA, Model Number: DYNJ63339C; bbb. TURP PACK SMGH-LF, Model Number: DYNJ41927B; ccc. ULTRASOUND PACK-LF, Model Number: PHS751646C, PHS751646D;

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

16,143 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: DYNJ40629B, UPC Number: 088827777869. b. Model Number: DYNJ81410B, UPC Number: 019532732082. c. Model Number: DYNJ901145G, UPC Number: 019348985021. d. Model Number: DYNJC9299M, UPC Number: 019348926312; Model Number: DYNJC9299O, UPC Number: 019532718840. e. Model Number: DYNJ24459P, UPC Number: 019348935534. f. Model Number: DYNJ36242, UPC Number: 088438951744. g. Model Number: DYNJ60667C, UPC Number: 019348940759; Model Number: DYNJ60667D, UPC Number: 019348986151; Model Number: DYNJ60667F, UPC Number: 019532702361; Model Number: DYNJ83942, UPC Number: 019532731798. h. Model Number: DYNJ905761A, UPC Number: 019348946321. i. Model Number: DYNJ68447B, UPC Number: 019532703416. j. Model Number: DYNJ69204A, UPC Number: 019532711427. k. Model Number: DYNJ901296B, UPC Number: 019348992335. l. Model Number: DYNJ66867A, UPC Number: 019348998623. m. Model Number: DYNJ0426069N, UPC Number: 019532737131. n. Model Number: DYNJ82517, UPC Number: 019532719864. o. Model Number: DYNJ44210B, UPC Number: 019348930685. p. Model Number: DYNJ63343G, UPC Number: 019532727346. q. Model Number: DYNJ48520, UPC Number: 088827790346. r. Model Number: CDS840214Q, UPC Number: 019532728990. s. Model Number: DYNJ907076A, UPC Number: 019348938164; Model Number: DYNJ907076B, UPC Number: 019348945045; Model Number: DYNJ907076C, UPC Number: 019348946561. t. Model Number: DYNJ58575B, UPC Number: 019348989550. u. Model Number: DYNJ0378388O, UPC Number: 019348956435. v. Model Number: DYNJ905634B, UPC Number: 019348963392. w. Model Number: DYNJ80290, UPC Number: 019532703724. x. Model Number: DYNJ0991320K, UPC Number: 019348956435. y. Model Number: DYNJ69914, UPC Number: 019348999641. z. Model Number: DYNJ68447, UPC Number: 019348944709; Model Number: DYNJ68447A, UPC Number: 019348991380. aa. Model Number: DYNJ68380, UPC Number: 019348943974; Model Number: DYNJ68380A, UPC Number: 019348991319; Model Number: DYNJ68380B, UPC Number: 019532703378. bb. Model Number: DYNJ0049595C, UPC Number: 019348980698; Model Number: DYNJ20495K, UPC Number: 019532737078. cc. Model Number: DYNJ57760, UPC Number: 088994277494. dd. Model Number: CDS982779L, UPC Number: 019348963341; Model Number: CDS982779M, UPC Number: 019348944627. ee. Model Number: DYNJ69204, UPC Number: 019348990830. ff. Model Number: DYNJ905366A, UPC Number: 019348975937; Model Number: DYNJ905366B, UPC Number: 019532704806. gg. Model Number: DYKMBNDL54A, UPC Number: 019532704487. hh. Model Number: DYNJ41208D, UPC Number: 019348929718. ii. Model Number: DYNJ80172, UPC Number: 019532701341; Model Number: DYNJ80172A, UPC Number: 019532712324; Model Number: DYNJ80172B, UPC Number: 019532735918. jj. Model Number: DYNJ68172A, UPC Number: 019348997493. kk. Model Number: DYNJ53059A, UPC Number: 088994241511. ll. Model Number: DYNJ906915, UPC Number: 019348928037. mm. Model Number: DYNJ69898A, UPC Number: 019532723505. nn. Model Number: DYNDA2418, UPC Number: 019348937821. oo. Model Number: DYNJ60242A, UPC Number: 019348924698. pp. Model Number: DYNJ0569950Q, UPC Number: 019348978281. qq. Model Number: DYNJ81751, UPC Number: 019532713931. rr. Model Number: DYNJ61747C, UPC Number: 019348936503. ss. Model Number: DYNJ908046C, UPC Number: 019532731349. tt. Model Number: DYNJ63879D, UPC Number: 019532722189. uu. Model Number: DYNJ52505A, UPC Number: 019348972485. vv. Model Number: DYNJ904219G, UPC Number: 019348948513; Model Number: DYNJ904343C, UPC Number: 019348982294. ww. Model Number: DYNJ904250F, UPC Number: 019348981399. xx. Model Number: DYNJ904254F, UPC Number: 019348945242. yy. Model Number: DYNJ905824D, UPC Number: 019348986150. zz. Model Number: DYNJRA0961A, UPC Number: 019348926312. aaa. Model Number: DYNJ63339C, UPC Number: 019348995807. bbb. Model Number: DYNJ41927B, UPC Number: 088994242830. ccc. Model Number: PHS751646C, UPC Number: 088994224535; Model Number: PHS751646D, UPC Number: 019532719680.

510(k) numbers

not on file

PMA numbers

not on file

Product code

FDE

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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