The Recall Desk
HighFDA (Devices)·Z-1716-2022·Announced 2022-09-21

Roadrunner UniGlide wire guide recalled for potential sterility compromise

Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their 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: FDA Class II medical device with potential sterility compromise due to failed packaging testing. No reported illnesses, injuries, or confirmed sterility breach. This qualifies as a risk-of-harm product where injury has not yet been reported, consistent with the High severity threshold.

Plain-English summary

Cook Incorporated has recalled 189 units of the Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPWAS-35-80, Order Number G56175). These devices are used in diagnostic and interventional vascular procedures to position and exchange catheters.

The recall was issued because these devices did not meet acceptance criteria for packaging testing, which included 3-year age acceleration testing. Consequently, the sterility of the recalled devices may be compromised. The affected lot numbers are 14174876, 14174880, NS14104906, NS14173970, and NS14173971.

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

The recalled product

Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular Devices
Hazard
Affected units
189

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 (5)

  • UDI-DI: (01)00827002561755- Lot Numbers: 14174876
  • 14174880
  • NS14104906
  • NS14173970
  • NS14173971

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 13 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 13 products in this recall →

Related recalls

Same manufacturer · Cook Incorporated

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Same hazard · sterility compromise

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