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Recall Observatory FDA recall evidence

Device product

Clarke-Reich Laparoscopic Knot Pusher

Z-2537-2017

April 25, 2017

Class II

Product summary

Firm
Cook Inc.
Event
Event 77217
Status
Terminated
Classification
Class II
Quantity
178
Official record key
device-enforcement:Z-2537-2017

Official wording

Reason: reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products

Code information: All lots Catalog numbers: J-CRKP-042900

Distribution pattern: The devices have been distributed nationwide within the United States and the following countries: Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products