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Recall Observatory FDA recall evidence

Device product

CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.

Z-2276-2012

June 01, 2012

Class II

Product summary

Firm
Advanced Sterilization Products
Event
Event 62919
Status
Terminated
Classification
Class II
Quantity
1,310,844 units
Official record key
device-enforcement:Z-2276-2012

Official wording

Reason: The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.

Code information: Product codes: 20390 (US).

Distribution pattern: Nationwide (USA) and Puerto Rico.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    missing labels