Cook Incorporated: Medical Device Recall in 2022 - (Recall #: Z-1714-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2022.

Data Source: FDA.

Product Description:

Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-80 ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional procedures.

Product Classification:

Class II

Date Initiated: July 19, 2022

Date Posted: September 21, 2022

Recall Number: Z-1714-2022

Event ID: 90710

Reason for Recall:

Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.

Status: Ongoing

Product Quantity: 75 units

Code Information:

UDI-DI: (01)00827002561724- Lot Numbers: 14156569

Distribution Pattern:

Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA

Voluntary or Mandated:

Voluntary: Firm initiated