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Recall Observatory FDA recall evidence

Device product

CaviWipes1 Extra Large, Part No. 13-5150 The brand name of the device is CaviWipes1 Extra Large, a surface disinfectant. The device has been assigned the product code LRJ (General Purpose Disinfectant) by the FDA and is classified as a Class I Medical Device. CaviWipes1 Extra Large is intended to be used to disinfect surfaces.

Z-1402-2017

January 20, 2017

Class II

Product summary

Firm
Metrex Research, LLC.
Event
Event 76318
Status
Terminated
Classification
Class II
Quantity
960 cases
Official record key
device-enforcement:Z-1402-2017

Official wording

Reason: Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.

Code information: Lot No. 16-2340PA

Distribution pattern: Nationwide Distribution to PA, FL, IL, MN, TX, AL, NY

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Metrex is recalling the CaviWipes Extra Large because they may have been contaminated during the packaging process.