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Terminated

3M Attest 1264P Biological Indicators, in boxes of 25 per box

FDA Recall Z-0237-04 · Posted 2003-12-18

Recalling Firm3m Health Care
Recall StatusTerminated
Product CodeFRC
Date Initiated2003-10-24
Date Terminated2005-02-09
Product Quantity1844 boxes of 25 biological indicators per box

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.

Firm 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.

Root Cause

Other

Distribution Pattern

The product was distributed nationwide in the United States and worldwide.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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