Home / Recalls / Medical Devices
3M Company - Health Care Business recalls 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air remova
Recalled October 4, 2023 · FDA recall Z-2640-2023 · 3M Company - Health Care Business
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. · FDA Class II
Units
77,280 devices
Sold at
Worldwide distribution - US Nationwide and the countries of Argentina, Australia, Belgium, Canada, China, Colombia, Hong Kong, Italy, Japan, Peru, Poland, South Korea, Spain, Taiwan.
Description
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.
Product
3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to qualify and monitor dynamic-air removal steam sterilization processes
Manufacturer(s)
3M Company - Health Care Business
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →