FDAFDA · Food and drugs·Recall number Z-1523-2013
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.
Published June 19, 2013 · Recall initiated: May 24, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Fenwal Inc
- Distributor
- USA Nationwide Distribution
- Lot
- Model No.: R4R2339; Lot No.: FA12C07070; Expiration Date: 03/2014
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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