ClearanceBrief
Recall Z-0779-03 ยท FRC Indicator, Biological Sterilization Process

3m Health Care

N/A

DateApr 22, 2003 (initiated Jan 9, 2002)
StatusTerminated
ReasonSome 3M Attest Steam Packs 1276F (biological indicator challenge for steam sterilization) were labeled as 3M Attest Rapid Readout Steam Pack 1296F.
Root causeOther
ActionA recall letter was sent to the consignees on January 8, 2002 and requested the return of the product.
DistributionDistribution was nationwide in the United States. There were no U.S. government accounts.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.