3M Attest 1264P Biological Indicators, in boxes of 25 per box
FDA device recall Z-0237-04 · posted 2003-12-18 · Terminated
Recall details
- Recalling firm
- 3m Health Care
- Reason for recall
- The 3M Attest 1264/1264P Biological Indicators of ETO sterilization contain a microbiological contaminant which can affect the performance of the positive control and the indicators to some limited extent. The color on a positive control may revert to negative after 24 hours of incubation.
- Action taken
- The firm conducted a field correction which began on 10/24/03. They provided revised labeling for the product. Letters, dated October 24, 2003, were sent to consignees. The letters had a description of the problem, instructions for doing the relabeling in the field, and recommendations for users of the product.
- Root cause
- Other
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 1844 boxes of 25 biological indicators per box
- Distribution
- The product was distributed nationwide in the United States and worldwide.
- Date initiated
- 2003-10-24
- Date posted
- 2003-12-18
- Date terminated
- 2005-02-09
- Location
- Saint Paul, MN
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