AMICUS Exchange Kit recall: Labeling Error
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure.…
Why was AMICUS Exchange Kit recalled?
Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339, Amicus Exchange Kits. Fenwal identified a labeling issue with this batch of Product Code R4R2339 (which was cleared for European use only) in which this batch was distributed within the United States market. The problem is identified as labeling that did not include the written description for the s
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?
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
- Product
- AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure.…
- Recalling firm
- Fenwal Inc
- Quantity
- 19 Cases (114 Units)
- Distribution
- USA Nationwide Distribution
- Recall date
- June 19, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)