ClearanceBrief
Recall Z-0375-04 ยท JOJ Indicator, Physical/Chemical Sterilization Process

Advanced Sterilization Products

Cidex Plus Test Strips

DateJan 29, 2004 (initiated Dec 17, 2003)
StatusTerminated
ReasonMay not accurately detect minimum effective concentration (MEC)
Root causeOther
ActionRecall was made by various emails sent 12/12/2003 to 12/19/2003. Customers are requested to quarantine and return product.
Quantity710 cases, 2 bottles per case
DistributionNationwide. Japan, Puerto Rico, Latin America, Caribbean.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.