CIDEX OPA Solution, ortho-Phthalaldehyde Solution
FDA device recall Z-0051-05 · posted 2004-10-28 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- Reason for recall
- Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MED
- Distribution
- Worldwide
- Date initiated
- 2004-04-12
- Date posted
- 2004-10-28
- Date terminated
- 2005-09-02
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) (K002401) | Advanced Sterilization Products | 2000-08-29 |