Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Class I - DangerousWhat Should You Do?
- Check if you have this product: Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)
- 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:
- Fenwal Inc
- Reason for Recall:
- Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Amicus Exchange Kit Therapeutics - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Product Codes/Lot Numbers:
Product Code X6R2349; UDI: 04086000101950; Batch Numbers FA20E25150 (Exp. 05/31/2022) and FA20I22142 (Exp. 09/30/2022)
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-1345-2021
Related Recalls
Amicus Exchange Kit Therapeutics. Component of Amicus Separator multiprocedural apheresis platform
Fenwal
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Potential for centrifuge packs to develop a stress leak for certain lots of Amicus MNC Apheresis kit and Amicus Exchange kit (Therapeutic Kits) on the Amicus Separator.
Some lots of Amicus MNC Apheresis and Amicus Exchange kits have leaking centrifuge packs during a procedure on the Amicus Separator using therapeutic protocols only. The defect is a blood leak at the boot, elbow, or in the channel on the separation chamber of the centrifuge pack.