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Recall Observatory FDA recall evidence

Device product

Willscher Vas Reapproximator Set, Surgical Instrument, Supplied sterilized by ethylene oxide gas in peel-open packages. Used to stabilize the vas ends during microscopic vasovasostomy.

Z-2310-2017

May 01, 2017

Class II

Product summary

Firm
Cook Inc.
Event
Event 77167
Status
Terminated
Classification
Class II
Quantity
327 lots, 364 units
Official record key
device-enforcement:Z-2310-2017

Official wording

Reason: COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

Code information: CATALOG NUMBER: 092000, GPN: G14500, Dates of Manufacture: January 2012 to March 2016,

Distribution pattern: Worldwide Distribution - US (nationwide) and countries of: Australia, Austria, Belgium, Bahrain, Canada, China, Costa Rica, Finland, France, Germany, Hong Kong, India, Ireland, Italy, Lithuania, Latvia, Malaysia, Netherlands, Romania, Russia, Saudi Arabia, Singapore, Spain, Switzerland, United Arab Emirates, and United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    COOK Medical is initiating a voluntary recall of multiple products because the reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products.

Field note

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