Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0953-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Bentson Wire Guide

Product Classification:

Class II

Date Initiated: October 13, 2017

Date Posted: March 21, 2018

Recall Number: Z-0953-2018

Event ID: 79195

Reason for Recall:

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

Status: Terminated

Product Quantity: 439,797

Code Information:

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

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated