3M Company - Health Care Business: 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal steam sterilization processes

Hazard

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.

Details from the source

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: Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan. Quantity: 172,464 devices Lot/code info: UDI/DI: 50707387787276( (shipper); Lot Codes: 33P3EF, exp. 12/27/2024; 33P4ND, exp. 01/01/2025; 33P4NR, exp. 01/01/2025; 33P5CA, exp. 01/03/2025; 33P5XT, exp. 01/06/2025

UPC codes

50707387787276

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.