Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLA

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. 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;

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: 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.

Quantity Affected: 16,143 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