Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877
- 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:
- Due to a manufacturing process resulting in holes/breaches in the Tyvek sterile barrier.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Melrose Wakefield Hospital REF K05T-2159 Injector And Syringe, Angiographic/Syringe, Balloon Inflation - The 30 ATM Monarch syringe is used to inflate and deflate balloon angioplasty catheters and to measure the pressure within the balloon during the procedure. It is also used to inject fluids into the body and to monitor the pressure of that fluid.
Product Codes/Lot Numbers:
Catalog Number: K05T-02159 UDI-DI code: 00884450140840 Lot Number: T2417859 T2434208 T2509792 T2549931 T2561788 T2625814 T2675576 T2762716 T2801089 T2893877
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-0062-2025
Related Recalls
Due to unsealed portions of pouches.
Philips Bridge Prep Kit REF: K12-09098C Sterile EO, Rx ONLY
Merit Medical Systems
catheter may experience resistance when being advanced over the guidewire
16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies, procedure delay, embolization/thrombosis, impaired catheter function, loss of vessel for future vascular access.