The Recall Desk
HighFDA (Devices)·Z-1718-2022·Announced 2022-09-21

Cook Roadrunner Hydrophilic Wire Guide Recalled for Potential Sterility Compromise

Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging sterility testing. The device's sterility may be compromised.

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 a Class II medical device recall where sterility may be compromised. While no illnesses or injuries have been reported and the hazard is potential rather than confirmed, a sterility failure in an invasive vascular device poses a meaningful risk of harm.

Plain-English summary

Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide, a medical device used for vascular catheter positioning and exchange in diagnostic and interventional procedures.

The device failed packaging acceptance testing, specifically 3-year age acceleration testing. This failure means the sterility of the affected units may be compromised.

The recalled devices were distributed nationwide and internationally, including to Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, United Kingdom, Greece, Guam, Hungary, Israel, Italy, Jordan, Japan, South Korea, Kuwait, Mexico, Malaysia, New Caledonia, Netherlands, Peru, Poland, Puerto Rico, Portugal, Paraguay, Russia, Sweden, Slovenia, Turkey, Uruguay, and South Africa. The affected lot number is 14156572.

If you have this device, contact Cook Incorporated for instructions on handling or replacement of the recalled product.

The recalled product

Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-80 ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular Device
Hazard
  • sterility-compromise
  • infection-risk

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)00827002561519- Lot Numbers: 14156572

Distribution

Distributed nationwide across the United States.

Related recalls

Same category