Recall Z-0051-05 ยท MED Sterilant, Medical Devices
Advanced Sterilization Products
CIDEX OPA Solution, ortho-Phthalaldehyde Solution
| Date | Oct 28, 2004 (initiated Apr 12, 2004) |
| Status | Terminated |
| 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. |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K002401 | CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION) Advanced Sterilization Products, Aug 29, 2000 |