Z-0963-2018 Class II Terminated
FDA device recall Z-0963-2018 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: 3,364.
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
- 3,364
Product Description
TFE Coated Curved Newton LLT
Reason for Recall
Label does not state that the product is heparin-coated.
Distribution Pattern
Nationally
Code Information
Catalog # TSCFNB-35-180-SPENCERMOD- BH Affected lots to include: 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180