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Class 2 Device Recall Wire Guide |
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Date Initiated by Firm |
January 04, 2019 |
Create Date |
February 04, 2020 |
Recall Status1 |
Terminated 3 on May 29, 2020 |
Recall Number |
Z-0964-2020 |
Recall Event ID |
82026 |
510(K)Number |
K082536
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Product Classification |
Endoscopic guidewire, gastroenterology-urology - Product Code OCY
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Product |
Wire Guide, Guidewire, Global Product Number G14326
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Code Information |
7857489 |
Recalling Firm/ Manufacturer |
Cook Inc. 750 N Daniels Way Bloomington IN 47404-9120
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For Additional Information Contact |
Cook Medical Customer Relations Department 800-457-4500
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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.
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FDA Determined Cause 2 |
Process control |
Action |
On 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 Commerce |
13388 total |
Distribution |
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. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = OCY and Original Applicant = COOK UROLOGICAL, INC.
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