Amicus Exchange Kit - Product Usage: intended for use recall
Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
Why was Amicus Exchange Kit - Product Usage: intended for use recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product Code X6R2339; UDI: 04086000100151; Batch Numbers FA20F08147 (Exp. 06/07/2022), FA20H12145 (Exp. 08/11/2022), FA20J27157 (Exp. 10/26/2022)
- Product
- Amicus Exchange Kit - Product Usage: intended for use in the collection of blood components and mononuclear cells.
- Recalling firm
- Fenwal Inc
- Quantity
- 2466 units
- Distribution
- US Nationwide distribution in the states of GA, TX, TN, MD, CA, KS, MN, MA, NM, NC, LA, CO, KY, NV, PA, UT, MI, NJ, IL, MD, OH, NY, FL.
- Recall date
- April 14, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)