Z-0963-2020 Class II Terminated
FDA device recall Z-0963-2020 was initiated by Cook Inc. on January 4, 2019 and is designated Class II. 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. The recall status is terminated (terminated May 29, 2020). Affected quantity: 13388 total.
Recall Details
- Product Type
- Devices
- Report Date
- February 12, 2020
- Initiation Date
- January 4, 2019
- Termination Date
- May 29, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13388 total
Product Description
Reason for Recall
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.