Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot # I2605742; UDI-DI: 00884450398166
- 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:
- There is a potential that valve assemblies will not open. preventing fluid from draining.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- ongoing
Product Information
Full Description:
Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F, REF 4992206 Version A, Sterile EO, Rx Only
Product Codes/Lot Numbers:
Lot # I2605742; UDI-DI: 00884450398166
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1908-2023
Related Recalls
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
Due to a manufacturing issue involving the silicone quad ring where the ring is deformed or otherwise damaged and may cause a foreign body in the fluid pathway.
Custom Manifold Kit: REF: K09-02239C, K09-02249UP, K09-09110B, K09-10294A, K09-11227A, K09-11456B, K09-12123B, K09-13342AP, K09-13391BP, K09-13548, K09-14000A, K09T-12020D, K09T-12275B
Merit Medical Systems
High pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use of the affected product may result in the trapped air being introduced into the patient.