Z-1523-2013 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- June 19, 2013
- Initiation Date
- May 24, 2013
- Termination Date
- August 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19 Cases (114 Units)
Product Description
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.
Reason for Recall
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
Distribution Pattern
USA Nationwide Distribution
Code Information
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014