Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0970-2020)

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:

Urethral Dilation Balloon Catheter with Open Tip , Global Product No. G17844

Product Classification:

Class II

Date Initiated: January 4, 2019

Date Posted: February 12, 2020

Recall Number: Z-0970-2020

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:

8494465 8513227 8537103 8537104 8552050 8552051 8567256 8576963 8632766 8639366 8659206 8683459 8754089 NS8513228

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