FDA-Device2013-06-19Class II
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.
Fenwal Inc
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
Sold states
USA Nationwide Distribution
Affected count
19 Cases (114 Units)
Manufactured in
3 Corporate Dr Ste 300, N/A, Lake Zurich, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1523-2013Don't want to check this manually?
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