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Class 2 Device Recall Roadrunner Hydrophilic PC 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-0963-2020 |
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 |
Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
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Code Information |
7853231 7853232 7853233 7853239 7853240 7853241 7853242 7853243 7853245 7853247 7901140 7901141 7982113 7982118 7982133 8050291 8241613 8241616 8252179 8252181 8252186 8258553 8283322 8407934 8460985 8474895 8474898 8474905 8474906 8474908 8474909 8474910 7936207 |
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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