Recall Z-2639-2023 ยท FRC Indicator, Biological Sterilization Process
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
| Date | Sep 26, 2023 (initiated Aug 22, 2023) |
| Status | Open, Classified |
| 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 132C and 135C. |
| Root cause | Process control |
| Action | 3M issued an Urgent product recall notice to its consignees on 08/24/2023 by email and US mail. The notice explained the problem with the product and requested the following: Discontinue distribution of the product and dispose of the product. Distributors were directed to notify their customers. The firm is offering replacement with the return of the completed response form. |
| Quantity | 172,464 devices |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193154 | 3M Attest Super Rapid 5 Steam-Plus Challenge Pack 3M Company, Feb 7, 2020 |