Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.

Class I - Dangerous

What Should You Do?

  1. Check if you have this product:
    Catalog Number/UDI-DI code/Lot Numbers: OPT0242-00 00884450400586 T2167632 T2651487 T2327975 T2528428 T2845197 S1279-01 00884450050804 T2281682 T2409038 T2415675 T2449554 T2479912 T2599987 T2610007 T2681504 T2662328 T2713161 T2832455 T2890627 T2748983 T2780193 S2953 00884450050842 T2538578 T2625990 T2548814 T2574370 T2643543 T2702839 T2702565S T2736331 T2801599 T2924139 T2839019 T2890680 T2847794 S2960 00884450389058 T2542575 T2637160 T2872115 S6002 0088445005239 T2208823
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Merit Medical Systems, Inc.
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.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: Custom Procedure Kit (Angiography/Angioplasty kit), REF: OPT0242-00 S1279-01 S2953 S2960 S6002 To support various vascular or cardiac diagnostic and interventional procedures.

Product Codes/Lot Numbers:

Catalog Number/UDI-DI code/Lot Numbers: OPT0242-00 00884450400586 T2167632 T2651487 T2327975 T2528428 T2845197 S1279-01 00884450050804 T2281682 T2409038 T2415675 T2449554 T2479912 T2599987 T2610007 T2681504 T2662328 T2713161 T2832455 T2890627 T2748983 T2780193 S2953 00884450050842 T2538578 T2625990 T2548814 T2574370 T2643543 T2702839 T2702565S T2736331 T2801599 T2924139 T2839019 T2890680 T2847794 S2960 00884450389058 T2542575 T2637160 T2872115 S6002 0088445005239 T2208823

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2573-2024

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