Device product
Amplatz Ultra Stiff Wire Guide
Z-0950-2018
Product summary
- Firm
- Cook Inc.
- Event
- Event 79195
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12,462
- Official record key
device-enforcement:Z-0950-2018
Official wording
Reason: Label does not state that the product is heparin-coated.
Code information: Catalog # THSF / ASG-BH Affected lot codes range from: 3730001 - 6164916 F3729969 - F4922979 NS4928020 - NS6203182 Affected lot codes range from: 3733552 - 6175191 F3729974 - F4923948 NS4927345 - NS6177894
Distribution pattern: Nationally
Derived failure modes
-
Labeling or packaging
Label does not state