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Recall Observatory FDA recall evidence

Device product

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

Z-2638-2023

August 22, 2023

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 92915
Status
Ongoing
Classification
Class II
Quantity
33504 devices
Official record key
device-enforcement:Z-2638-2023

Official wording

Reason: 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.

Code information: UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.