Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CIDEX OPA Solution, ortho-Phthalaldehyde Solution

FDA Recall Z-0051-05 · Posted 2004-10-28

Recalling FirmAdvanced Sterilization Products
Recall StatusTerminated
Product CodeMED
Date Initiated2004-04-12
Date Terminated2005-09-02

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.

Firm 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.

Root Cause

Other

Distribution Pattern

Worldwide

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K002401CIDEX OPA SOLUTION (0.55% ORTHRO-PHTHALALDEHYDE SOLUTION)Advanced Sterilization Products · 2000-08-29

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑