Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0950-2018)

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:

Amplatz Ultra Stiff Wire Guide

Product Classification:

Class II

Date Initiated: October 13, 2017

Date Posted: March 21, 2018

Recall Number: Z-0950-2018

Event ID: 79195

Reason for Recall:

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

Status: Terminated

Product Quantity: 12,462

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

Voluntary or Mandated:

Voluntary: Firm initiated