FDA Medical Device Recalls (openFDA)
Advanced Sterilization Products: CIDEX OPA Solution, ortho-Phthalaldehyde Solution
- Recall number
- Z-0051-05
- Recalling firm
- Advanced Sterilization Products
- Product
- CIDEX OPA Solution, ortho-Phthalaldehyde Solution
- Status
- Terminated
- Initiated
- 2004-04-12
- Posted
- 2004-10-28
- Terminated
- 2005-09-02
- Reason
- Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
- Root cause
- Other
- Action
- Firm conducted WebEx meeting with affiliates on April 12 & 13, 2004 to discuss CIDEX OPA Solution labeling. April 23, 2004, Firm sent letters to affiliates, customers, and end users to notify of new contraindication for CIDEX OPA Solution. Same letter was sent to U.S. Healthcare facilities on April 23, 2004; to Urology M.D.s on April 28, 2004; to Urologist Nurses on May 7, 2004. Customers can call 800-370-4632 with questions.
- Quantity
- not on file
- Distribution
- Worldwide
- Lot, serial or model codes
- Product Code: 20390, 20391, 20394
- 510(k) numbers
- ["K002401"]
- PMA numbers
- not on file
- Product code
- MED
- 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