Z-2307-2023 Class II Ongoing

Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION/DRAINAGE PACK, Model Number: DYNJ53658B; b. BASIC BIOPSY TRAY, Model Number: DYNDH1534; c. BIOPSY PACK, Model Number: DYNDH1124, DYNJ50485; d. BIOPSY PACK-LF, Model Number: DYNJ0747885G; e. BIOPSY RAD CT, Model Number: DYNJ59752A; f. BIOPSY TRAY, Model Number: DYNDH1748, DYNJ34637F, DYNJ34637G, DYNJ43076, DYNJ43076A, DYNJ62690; g. BIOPSY WITH PROB COVER WRO-LF, Model Number: DYNJ42307A; h. BREAST BIOPSY KIT, Model Number: DYNDA1224B; i. BREAST BIOPSY TRAY, Model Number: DYNDH1266, DYNDH1302, DYNDH1345A, DYNDH1677; j. CABARRUS BIOPSY TRAY, Model Number: DYNDH1670; k. CORE BIOPSY PACK-LF, Model Number: DYNJ42752A; l. GENERAL BIOPSY PACK, Model Number: P365500; m. IGT BIOPSY PACK-LF, Model Number: DYNJ38616A; n. IR BIOPSY PACK, Model Number: DYNJ63688I; o. PROSTATE BIOPSY, Model Number: DYNJVB91015A; p. PROSTATE BIOPSY PACK, Model Number: DYNJ56578; q. RENAL BIOPSY TRAY, Model Number: SPEC0168; r. REVAMP BIOPSY TRAY, Model Number: DYNDH1147A; s. SOFT TISSUE BIOPSY, Model Number: DYNDH1750; t. THYROID BIOPSY TRAY, Model Number: DYNDH1288; u. U/S CORE BIOPSY KIT, Model Number: DYNDH1121C; v. UL BIOPSY TRAY, Model Number: DYNDH1778; w. ULTRASOUND BIOPSY, Model Number: DYNDH1542B; x. ULTRASOUND BREAST BIOPSY, Model Number: DYNDH1496A; y. ULTRASOUND CORE BIOPSY TRAY, Model Number: DYNDH1786; z. US BREAST BIOPSY PACK, Model Number: DYNJ61992B;

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

All lot numbers for the following models and corresponding UPCs distributed from Medline between 04/01/2020 and 04/28/2023: a. Model Number: DYNJ53658B, UPC Number: 019532708870. b. Model Number: DYNDH1534, UPC Number: 019348919708. c. Model Number: DYNDH1124, UPC Number: 088994230327; Model Number: DYNJ50485, UPC Number: 088827799279; Model Number: DYNDH1124, UPC Number: 10889942303274. d. Model Number: DYNJ0747885G, UPC Number: 019532708872. e. Model Number: DYNJ59752A, UPC Number: 019348959857. f. Model Number: DYNDH1748, UPC Number: 019532716474; Model Number: DYNJ34637F, UPC Number: 019348956435; Model Number: DYNJ34637G, UPC Number: 019348936880; Model Number: DYNJ43076, UPC Number: 088827702453; Model Number: DYNJ43076A, UPC Number: 019532708062; Model Number: DYNJ62690, UPC Number: 019348968226. g. Model Number: DYNJ42307A, UPC Number: 088827729875. h. Model Number: DYNDA1224B, UPC Number: 019348946851. i. Model Number: DYNDH1266, UPC Number: 088994267045; Model Number: DYNDH1302, UPC Number: 088994276804; Model Number: DYNDH1345A, UPC Number: 088827773293; Model Number: DYNDH1677, UPC Number: 019532704448. j. Model Number: DYNDH1670, UPC Number: 019532701068. k. Model Number: DYNJ42752A, UPC Number: 088994232609. l. Model Number: P365500, UPC Number: 088994214185. m. Model Number: DYNJ38616A, UPC Number: 088438975595. n. Model Number: DYNJ63688I, UPC Number: 019532703723. o. Model Number: DYNJVB91015A, UPC Number: 019348933972. p. Model Number: DYNJ56578, UPC Number: 088994265947. q. Model Number: SPEC0168, UPC Number: 088438986986. r. Model Number: DYNDH1147A, UPC Number: 019348934879. s. Model Number: DYNDH1750, UPC Number: 019532716642. t. Model Number: DYNDH1288, UPC Number: 088994272663. u. Model Number: DYNDH1121C, UPC Number: 019348946865. v. Model Number: DYNDH1778, UPC Number: 019532722847. w. Model Number: DYNDH1542B, UPC Number: 019532725147. x. Model Number: DYNDH1496A, UPC Number: 019348982531. y. Model Number: DYNDH1786, UPC Number: 019532722955. z. Model Number: DYNJ61992B, UPC Number: 019532729265.