Cook Inc.: Medical Device Recall in 2018 - (Recall #: Z-0960-2018)

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:

Newton Wire Guide

Product Classification:

Class II

Date Initiated: October 13, 2017

Date Posted: March 21, 2018

Recall Number: Z-0960-2018

Event ID: 79195

Reason for Recall:

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

Status: Terminated

Product Quantity: 41,113

Code Information:

Catalog #THSCFNB-/-BH TSCFNA-BH TSCFNB-/-BH TSFNA-/-BH TSFNB-/-BH Affected lots range from: 3733537 - 5803299 F3762971 - F4692445 NS5043714 - NS5900771 3766161 - 5925080 F3753484 - F4887253 NS4938982 - NS5932560 F4556472 - F4718761 NS6024246 3741877 - 5929842 F3749985 - F4903656 NS4928037 - NS5963186 3744567 - 6253002 F3763300 - F4900931 NS4928039 - NS59824 3741882 - 6142463 F3884311 - F4903643 NS5044201 - NS5963180

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated