Reported Jun 19, 2013 · Terminated
AMICUS Exchange Kit; Product Usage: This kit is designed for use with the AMICUS separator for the Therapeutic Plasma…
Fenwal Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Fenwal Inc · 3 Corporate Dr Ste 300 · Lake Zurich, IL · 60047-8930
Is this the product you have?
- AMICUS Exchange Kit
- Product UsageThis 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
- Lot codes and dates
Model No.: R4R2339Lot No.: FA12C07070
- Expiration Date03/2014
- Amount recalled
- 19 Cases (114 Units)
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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