Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3029-2018 — Edwards Lifesciences Thin-Flex Single Stage Venous Drainage Cannula, 38FRX40CM, resterilized.

U.S. FDA — Device Enforcement · United States · 2018-03-07 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-3029-2018
Date of alert
2018-03-07
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
SPS Sterilization, Inc
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
59634935
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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