Cook Inc.: Medical Device Recall in 2020 - (Recall #: Z-0968-2020)

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:

Percutaneous Malecot Nephrostomy Set, Global Product No. G16714 G19107 G19108

Product Classification:

Class II

Date Initiated: January 4, 2019

Date Posted: February 12, 2020

Recall Number: Z-0968-2020

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:

NS8070854 8078209 8116743

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