Z-2557-2024 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- August 21, 2024
- Initiation Date
- June 11, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2388 kits
Product Description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Rapid Response Waste Management System Kit, REF BRC-BAL-INT-SL/B An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals.
Reason for Recall
Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.
Distribution Pattern
U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.
Code Information
Catalog Number / UDI-DI / Lot Numbers: BRC-BAL-INT-SL/B 00884450363102 T2581281 BRC-BAL-INT-SL/B 00884450363102 T2594451 BRC-BAL-INT-SL/B 00884450363102 T2606225 BRC-BAL-INT-SL/B 00884450363102 T2609782 BRC-BAL-INT-SL/B 00884450363102 T2628321 BRC-BAL-INT-SL/B 00884450363102 T2643945 BRC-BAL-INT-SL/B 00884450363102 T2685079 BRC-BAL-INT-SL/B 00884450363102 T2712303 BRC-BAL-INT-SL/B 00884450363102 T2745782 BRC-BAL-INT-SL/B 00884450363102 T2758208 BRC-BAL-INT-SL/B 00884450363102 T2800973 BRC-BAL-INT-SL/B 00884450363102 T2805964 BRC-BAL-INT-SL/B 00884450363102 T2846532 BRC-BAL-INT-SL/B 00884450363102 T2846539 BRC-BAL-INT-SL/B 00884450363102 T2850757 BRC-BAL-INT-SL/B 00884450363102 T2901641