3M Company – Health Care Business Recall 92915
Description: 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
3M Company – Health Care Business Recall 92915 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-2637-2023 |
| Event ID | 92915 |
| Event Description | 3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles |
| Product Type | 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. |
| Quantity | 79500 devices |
| Recall 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. |
| Device Classification | 20231004 |
| Device Code Info | UDI/DI: 50707387762969 (shipper), 30707387762965 (carton); Lot codes: 33P3X3, exp. 12/29/2024; 33P4NH, exp. 01/01/2025 |
| Center Classification Date | 20230926 |
| Recall Initiation Date | 20230822 |
| Recalling Firm | 3M Company - Health Care Business |
| Initial Notification | N/A |
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