Device product
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma Exchange (TPE) procedure. Sterilized by irradiation. Sterile fluid path. Non-pyrogenic fluid path.
Z-1523-2013
Product summary
- Firm
- Fenwal Inc
- Event
- Event 65296
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19 Cases (114 Units)
- Official record key
device-enforcement:Z-1523-2013
Official wording
Reason: 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
Code information: Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
Distribution pattern: USA Nationwide Distribution
Derived failure modes
-
Unknown
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