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

Recall Z-0604-2014 — STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.

U.S. FDA — Device Enforcement · United States · 2013-11-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0604-2014
Date of alert
2013-11-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Advanced Sterilization Products
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
14913706
Reported risk: Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.
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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