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Terminated

3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box

FDA Recall Z-0720-04 · Posted 2004-07-20

Recalling Firm3M Company / Medical Division
Recall StatusTerminated
Product CodeFRC
Date Initiated2004-02-27
Date Terminated2006-12-28
Product Quantity90,000 ampoules

Reason for Recall

The 3M Attest 1292 Rapid Readout Biological Indicators for steam sterilization may contain ampoules which may result in a false negative readout at 3 hours.

Firm Action

A Product Recall Notice was sent on February 27, 2004 to consignees instructing them to discontinue use of the recalled product and return products to 3M.

Root Cause

Other

Distribution Pattern

Nationwide throughout 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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