Cidex Plus Solution Test Strips
FDA Recall Z-0695-03 · Posted 2003-03-29
Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product Code6885
Date Initiated2003-02-14
Date Terminated2004-09-27
Product Quantity10,047 cases, (2 bottles per case)
Reason for Recall
Test strips which are used for QC of sterilant solution fail due to ingress of moisture.
Firm Action
Several emails and letters were sent between 2/14/03 and 2/27/03 to customers requesting return of product and also advising them that should return not be a viable option due to availability of replacements, a suggested temporary QC procedure could be used to separate good lots of strips from affected lots.
Root Cause
Other
Distribution Pattern
Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.