FDA-Device2018-09-19Class II
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
SPS Sterilization, Inc
Hazard
The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.
Sold states
US distribution to AZ, CA, FL, OH, PA, TX, VA, WV
Affected count
10 units total
Manufactured in
1110 N Gerald St, N/A, Nixa, MO, United States
Products
Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3029-2018Don't want to check this manually?
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