The Recall Desk
HighFDA (Devices)·Z-1714-2022·Announced 2022-09-21

Vascular Wire Guide Recalled Due to Sterility Concerns From Packaging Failure

Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Lot 14156569) because packaging testing failed, indicating the device's sterility may be compromised. The recall affects 75 units distributed in the U.S. and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II medical device with a potential sterility compromise, which poses a risk of infection and complications in vascular procedures. No illnesses or injuries have been reported, and the hazard is theoretical, placing the score at the maximum of 3 under the rubric.

Plain-English summary

Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Reference Part Number HPWA-35-80, Order Number G56172), which are used in vascular catheter positioning and exchange during diagnostic and interventional procedures. The recall involves 75 units from Lot 14156569.

The product did not meet acceptance criteria for packaging testing, which included 3-year age acceleration testing. As a result, the sterility of the device may be compromised.

The recalled devices were distributed nationwide in the United States and internationally to multiple countries including Canada, Japan, Australia, Germany, France, and others.

Healthcare providers who have obtained or used this device should contact their supplier or Cook Incorporated immediately. Affected devices should not be used until sterility can be confirmed.

The recalled product

Product
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.
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular catheter guide
Hazard
  • sterility-compromise

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category