FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: Cidex Plus Solution Test Strips
- Recall number
- Z-0695-03
- Recalling firm
- Advanced Sterilization Products
- Product
- Cidex Plus Solution Test Strips
- Status
- Terminated
- Initiated
- 2003-02-14
- Posted
- 2003-03-29
- Terminated
- 2004-09-27
- Reason
- Test strips which are used for QC of sterilant solution fail due to ingress of moisture.
- Root cause
- Other
- 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.
- Quantity
- 10,047 cases, (2 bottles per case)
- Distribution
- Nationwide. Australia, Brazil, Canada, Puerto Rico, Colombia, Japan, Korea, South Africa, Thailand, England, Uruguay, Venezuela, Republic of Panama.
- Lot, serial or model codes
- Cidex Plus, product code 2924, lots: 8423 8560 9229 Cidex Plus, Product code 2926, lots: 8312 8658 9120
- 510(k) numbers
- ["K981054"]
- PMA numbers
- not on file
- Product code
- 6885
- Firm FEI
- 3003662624
- Firm city
- Irvine
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28