Z-2571-2024 Class II Ongoing
FDA device recall Z-2571-2024 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: 900 kits.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2024
- Initiation Date
- Jun 11, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 kits
Product Description
Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG (Introducer Catheter), REF: FCL-069-00/A FCL-069-02/A FCL-069-03/A For the introduction of various types of pacing or defibrillator leads and catheters.
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: FCL-068-00/A 00884450484326 I2902415 I2828530 FCL-069-02/A 00884450484340 I2828531 I2838807 I2851067 I2853918 I2868010 FCL-069-03/A 00884450484357 I2853921
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2571-2024
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026