3M Attest 1264P Biological Indicators, in boxes of 25 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-0237-04

Quantity

1844 boxes of 25 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 DW, 2005-08 DD, and 2005-08 DL

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.