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;
This recall is currently active, issued August 3, 2023. It was issued by Medline Industries, Lp - Northfield.
- Recall Initiated
- May 15, 2023
- Posted
- August 3, 2023
- Recall Number
- Z-2307-2023
- Quantity
- 43,613 kits
- Firm Location
- Northfield, IL
- Official Source
- View on FDA website ↗
Reason for Recall
Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.
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: 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.
Root Cause
Nonconforming Material/Component
Action Taken
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.