3M Attest Rapid Readout 1292 Biological Indicators (Steam) Pack 70-2006-2052-7, Lot 2006-21, in boxes of 50 per box
FDA device recall Z-0720-04 · posted 2004-07-20 · Terminated
Recall details
- Recalling firm
- 3M Company / Medical Division
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRC
- Quantity affected
- 90,000 ampoules
- Distribution
- Nationwide throughout the United States and worldwide.
- Date initiated
- 2004-02-27
- Date posted
- 2004-07-20
- Date terminated
- 2006-12-28
- Location
- St Paul, MN
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