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Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the...

FDA Device Recall #Z-2307-2023 — Class II — May 15, 2023

Recall Summary

Recall Number Z-2307-2023
Classification Class II — Moderate risk
Date Initiated May 15, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm MEDLINE INDUSTRIES, LP - Northfield
Location Northfield, IL
Product Type Devices
Quantity 43,613 kits

Product Description

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;

Reason for Recall

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

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, China, Costa Rica, India, Lebanon, Panama, Qatar, Saudi Arabia, Singapore, United Arab Emirates.

Lot / 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: 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.

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Frequently Asked Questions

Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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