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

3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes — recall Z-2638-2023

U.S. FDA — Device Enforcement · United States · 2023-08-22 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-2638-2023
Date of alert
2023-08-22
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
3M Company - Health Care Business
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
50707387762983
Reported risk: Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5 Steam-Plus Challenge (41482V, 41482VF), and 3M Attest Super Rapid Readout Steam Challenge (1496V) may contain biological indicators with a cap that melts, deforms and/or cracks following a steam sterilization cycle of 132¿C and 135¿C.
Primary source: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRes/res.cfm?start_search=1&

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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