Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0963-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866

Product Classification:

Class II

Date Initiated: January 4, 2019

Date Posted: February 12, 2020

Recall Number: Z-0963-2020

Event ID: 82026

Reason for Recall:

The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.

Status: Terminated

Product Quantity: 13388 total

Code Information:

7853231 7853232 7853233 7853239 7853240 7853241 7853242 7853243 7853245 7853247 7901140 7901141 7982113 7982118 7982133 8050291 8241613 8241616 8252179 8252181 8252186 8258553 8283322 8407934 8460985 8474895 8474898 8474905 8474906 8474908 8474909 8474910 7936207

Distribution Pattern:

Domestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.

Voluntary or Mandated:

Voluntary: Firm initiated