FDA Enforcement
Class II
Terminated
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.
Recall: Z-1523-2013
·
Reported June 19, 2013
Enforcement
- Recall Number
- Z-1523-2013
- Event ID
- 65296
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Fenwal Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 19, 2013
- Initiation Date
- May 24, 2013
- Classification Date
- June 8, 2013
- Termination Date
- August 1, 2016
- Address
- 3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, 60047-8930, United States
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
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 Info
Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
Distribution
USA Nationwide Distribution
Quantity
19 Cases (114 Units)