Recall Z-0236-04 ยท FRC Indicator, Biological Sterilization Process
3m Health Care
3M Attest 1264 Biological Indicators, in boxes of 100 per box
| Date | Dec 18, 2003 (initiated Oct 24, 2003) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | 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. |
| Quantity | 9592 boxes of 100 biological indicators per box |
| Distribution | The product was distributed nationwide in the United States and worldwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.