Recall Z-2637-2023
3M Company - Health Care Business · initiated August 22, 2023
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
3M Attest Super Rapid Readout Biological Indicator, REF 1492V; used to qualify or monitor dynamic-air-removal steam sterilization cycles
Codes / lots: UDI/DI: 50707387762969 (shipper), 30707387762965 (carton); Lot codes: 33P3X3, exp. 12/29/2024; 33P4NH, exp. 01/01/2025
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 132C and 135C.
FDA-determined cause: Process control
Action taken
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.
Details
- Recall number
- Z-2637-2023
- Initiated
- August 22, 2023
- Posted by FDA
- September 26, 2023
- Product code
- FRC – Indicator, Biological Sterilization Process
- Quantity
- 79500 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.
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2638-2023 Class II | 3M Attest Super Rapid Readout Steam Challenge Pack, REF 1496V; designed to qualify and…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 08/22/2023Open, Classified |
| Z-2639-2023 Class II | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 08/22/2023Open, Classified |
| Z-2640-2023 Class II | 3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482VF; designed to…Specific lots of 3M Attest Super Rapid Readout Biological Indicators (1492V), 3M Attest Super Rapid 5… | 08/22/2023Open, Classified |