Device product

Movable Core Wire Guide

Z-0959-2018

October 13, 2017

Class II

Product summary

Firm: Cook Inc.
Event: Event 79195
Status: Terminated
Classification: Class II
Quantity: 21,913
Official record key: device-enforcement:Z-0959-2018

Official wording

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

Code information: Catalog # TCMTNA-/-BH TMT-/-BH TSFNA-/-BH Affected lots range from: 3774481 - 6145673 F3876320 - F4894841 NS4963396 - NS5144675 F4608907 3758468 - 6167814

Distribution pattern: Nationally

Derived failure modes

Labeling or packaging
reason.labeling_packaging · v1.0.0

Label does not state