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

Recall Z-0153-2016 — OneTray Sealed Sterilization Containers Product Usage: A rigid sterilization container used to steam sterilize medical devices

U.S. FDA — Device Enforcement · United States · 2014-02-03 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0153-2016
Date of alert
2014-02-03
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Innovative Sterlization Technologies LLC
Product category
device
Product type
Devices
Reported risk: The wrong sterilization time was on the label. The label lists Steam Gravity 10 - 34 minutes at 270 degrees F instead of Steam Gravity 17 - 34 minutes at 270 degrees F.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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