Z-2570-2024 Class II Ongoing
FDA device recall Z-2570-2024 was initiated by Merit Medical Systems, Inc. on Jun 11, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 7442 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2024
- Initiation Date
- Jun 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7442 kits
Product Description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: ReSolve (Catheter and Tip Suction kit), REF: RTT14038MB/A The ReSolve Thoracostomy Tray is indicated for the percutaneous removal of air and fluid from the pleural space.
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 code/Lot Numbers: RTT14038MB/A 00884450680100 T2882458 T2775532 T2692992 T2745797 T2823440 T2758669 T2882467 T2855297 T2692990 T2864420 T2762237 T2701080 T2748465 T2872143 T2853478 T2865442 T2560919 T2607047 T2617261 T2933737 T2657108 T2886240
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2570-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026