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U.S. Department of Health and Human Services

Class 2 Device Recall PTFE Wire Guide

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 Class 2 Device Recall PTFE Wire Guidesee related information
Date Initiated by FirmJanuary 04, 2019
Create DateFebruary 04, 2020
Recall Status1 Terminated 3 on May 29, 2020
Recall NumberZ-0962-2020
Recall Event ID 82026
510(K)NumberK082536 
Product Classification Endoscopic guidewire, gastroenterology-urology - Product Code OCY
ProductPTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Code Information 7832498 7832499 7832500 7925385 7925387 7930517 8090868 8287793 8287794 8287799 8400121 8548813 8548815 NS8548814 7760235 7881599 8062433 8074027 8290383 8290384 8404559 8404562 7999663 8077582 8077583 8065959 8073949 8074014 8074015 
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		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.
FDA Determined
Cause 2		Process control
ActionOn January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.
Quantity in Commerce3929
DistributionDomestic 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OCY
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