Various Merit Medical convenience kits that contain recalled Jiangsu Shenli Medical Production Co. Ltd. syringes: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number/UDI-DI code/Lot Numbers: FCL-083-02/A 00884450484418 I2808956 I2851068 I2868011 I2931690 WOR-CSG-B1-09/A 00884450484319 I2786685 I2808954 I2818469 I2818470 I2818471 I2828532 I2828533 I2838811 I2851070 I2853922 I2853923 I2868006 I2868008 I2879275 I2889546 I2889548 I2893943 I2901154 I2902413 I2902414 I2912319 I2941927 WOR-CSG-B2-09/A 00884450484456 I2786687 I2818472 I2828534 I2838814 I2853925 I2868009 I2879276 I2889549 I2901183 WOR-CSG-BL1-09/A 00884450484463 I2902412 I2912321 WOR-CSG-E-90/A 00884450484487 I2803269 I2851069 I2931689
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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: SafeSheath CSG/Worley advanced CSG (Introducer Catheter kit), REF: FCL-083-02/A WOR-CSG-B1-09/A WOR-CSG-B2-09/A WOR-CSG-BL1-09/A WOR-CSG-E-90/A For the introduction of various types of pacing or defibrillator leads and catheters.
Product Codes/Lot Numbers:
Catalog Number/UDI-DI code/Lot Numbers: FCL-083-02/A 00884450484418 I2808956 I2851068 I2868011 I2931690 WOR-CSG-B1-09/A 00884450484319 I2786685 I2808954 I2818469 I2818470 I2818471 I2828532 I2828533 I2838811 I2851070 I2853922 I2853923 I2868006 I2868008 I2879275 I2889546 I2889548 I2893943 I2901154 I2902413 I2902414 I2912319 I2941927 WOR-CSG-B2-09/A 00884450484456 I2786687 I2818472 I2828534 I2838814 I2853925 I2868009 I2879276 I2889549 I2901183 WOR-CSG-BL1-09/A 00884450484463 I2902412 I2912321 WOR-CSG-E-90/A 00884450484487 I2803269 I2851069 I2931689
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2577-2024
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