3M Attest 1264 Biological Indicators, in boxes of 100 per box
This recall has been terminated (originally issued December 18, 2003).
- Recall Initiated
- October 24, 2003
- Posted
- December 18, 2003
- Terminated
- February 9, 2005
- Recall Number
- Z-0236-04
- Quantity
- 9592 boxes of 100 biological indicators per box
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
The product was distributed nationwide in the United States and worldwide.
Lot / Code Info
Lot numbers 2005-07 DR, 2005-07 DS, 2005-07 DT, 2005-07 DU, 2005-08 DA, 2005-08 DB, 2005-08 DC, 2005-08 DN, and 2005-08 DO
Root Cause
Other
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.