Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.
FDA device recall Z-0694-03 · posted 2003-03-29 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture.
- Action taken
- 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
- Status
- Terminated
- Product code
- 6885
- Quantity affected
- 22,992 cases (2 bottles per case)
- Distribution
- Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.
- Date initiated
- 2003-02-14
- Date posted
- 2003-03-29
- Date terminated
- 2004-09-27
- Location
- Irvine, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BROWNE GA INDICATOR USE IN 2% ACTIV GLUTARALDEHYDE (K922481) | Board of Directors, Albert Browne , Ltd. | 1994-06-02 |