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U.S. Department of Health and Human Services

Class 2 Device Recall CIDEX OPA Solution

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 Class 2 Device Recall CIDEX OPA Solutionsee related information
Date Initiated by FirmApril 12, 2004
Date PostedOctober 28, 2004
Recall Status1 Terminated 3 on September 02, 2005
Recall NumberZ-0051-05
Recall Event ID 29903
510(K)NumberK002401 
Product Classification Sterilant, Medical Devices - Product Code MED
ProductCIDEX OPA Solution, ortho-Phthalaldehyde Solution
Code Information Product Code: 20390, 20391, 20394
Recalling Firm/
Manufacturer		 Advanced Sterilization Products
33 Technology Dr
Irvine CA 92618-2346
For Additional Information ContactElizabeth L. MacAdams, CQA, RAC
800-370-4632
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionFirm 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.
DistributionWorldwide
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MED
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