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Recall Observatory FDA recall evidence

Device product

Urethral Dilator Set, Global Product No. G14185

Z-0971-2020

January 04, 2019

Class II

Product summary

Firm
Cook Inc.
Event
Event 82026
Status
Terminated
Classification
Class II
Quantity
13388 total
Official record key
device-enforcement:Z-0971-2020

Official wording

Reason: The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Code information: 8401849 8404945 8404946 8417702 8404946X

Distribution pattern: Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.