Device product

Bentson Wire Guide

Z-0953-2018

October 13, 2017

Class II

Product summary

Firm: Cook Inc.
Event: Event 79195
Status: Terminated
Classification: Class II
Quantity: 439,797
Official record key: device-enforcement:Z-0953-2018

Official wording

Reason: Label does not state that the product is heparin-coated.

Code information: Catalog # TSFB-/-BH Affected lots include: F3813488 - F4859795 NS5327890 - NS6060291 3730884 - 5984142 F3746894 - F4920488 NS4937520 - NS6252870

Distribution pattern: Nationally

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Label does not state