3M Attest Super Rapid 5 Steam-Plus Steam Challenge Pack, REF 41482V; designed to qualify and monitor dynamic-air removal
FDA device recall Z-2639-2023 · posted 2023-09-26 · Open, Classified
Recall details
- Recalling firm
- 3M Company - Health Care Business
- 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.
- 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.
- Root cause
- Process control
- Status
- Open, Classified
- Product code
- FRC
- Quantity affected
- 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.
- Date initiated
- 2023-08-22
- Date posted
- 2023-09-26
- Location
- Saint Paul, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 3M Attest Super Rapid 5 Steam-Plus Challenge Pack (K193154) | 3M Company | 2020-02-07 |