Z-0962-2018 Class II Terminated
FDA device recall Z-0962-2018 was initiated by Cook Inc. on October 13, 2017 and is designated Class II. Reason for recall: Label does not state that the product is heparin-coated. The recall status is terminated (terminated October 23, 2019). Affected quantity: 98,502.
Recall Details
- Product Type
- Devices
- Report Date
- March 21, 2018
- Initiation Date
- October 13, 2017
- Termination Date
- October 23, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 98,502
Product Description
Rosen Curved Wire Guide
Reason for Recall
Label does not state that the product is heparin-coated.
Distribution Pattern
Nationally
Code Information
Catalog # TDW-/-SGH-BH Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894