Z-2638-2023 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- October 4, 2023
- Initiation Date
- August 22, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 33504 devices
Product Description
3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and monitor dynamic-air removal steam sterilization processes
Reason for Recall
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.
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.
Code Information
UDI/DI: 50707387762983( (shipper); Lot codes: 33P4NJ, exp. 01/01/2025; 33P56T, exp. 01/02/2025