ClearanceBrief
Recall Z-0779-05 ยท JOJ Indicator, Physical/Chemical Sterilization Process

Advanced Sterilization Products

Cidexplus Solution Test Strips

DateApr 27, 2005 (initiated Mar 16, 2005)
StatusTerminated
ReasonCIDEX test strips were found to pass solution below MEC.
Root causeOther
ActionCustomers were notified via urgent product recall letter dated March 16, 2005, to return the product for replacement.
Quantity3422 cases (2 bottles per case)
DistributionNationwide & Puerto Rice
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K981054BROWNE GA INDICATOR FOR CIDEX PRODUCTS
Albert Browne , Ltd., Dec 7, 1998