Class 2 Device Recall Custom Sterile and NonSterile Procedural Kits containing Turkuaz Ultrasound Gel

• Date Initiated by Firm: May 15, 2023
• Date Posted: August 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2312-2023
• Recall Event ID: 92399
• Product Classification: laparoscopy kit - Product Code FDE
• 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
• Code Information: 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.
• Recalling Firm/ Manufacturer: MEDLINE INDUSTRIES, LP - Northfield ; 3 Lakes Dr; Northfield IL 60093-2753
• For Additional Information Contact: Karin Johnson; 886-359-1704
• Manufacturer Reason for Recall: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
• FDA Determined 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 in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.