PTFE Wire Guide recall
PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
Why was PTFE Wire Guide recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- PTFE Wire Guide, Guidewire, Global Product Number 638813 635413-10
- Recalling firm
- Cook Inc.
- Quantity
- 3929
- 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.
- Recall date
- February 12, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)