FDA recall Z-0959-2018
Cook Inc. · Class II · device
Product
Movable Core Wire Guide
Reason for recall
Label does not state that the product is heparin-coated.
Distribution
Nationally
Key facts
- Status
- Terminated
- Initiation date
- 2017-10-13
- Report date
- 2018-03-21
- Termination date
- 2019-10-23
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Bloomington, IN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0959-2018