The Recall Desk
HighFDA (Devices)·Z-1712-2022·Announced 2022-09-21

Roadrunner UniGlide Hydrophilic Wire Guide Sterility Compromise Recall

Cook Incorporated is recalling 35 units of Roadrunner UniGlide Hydrophilic Wire Guide due to packaging testing failures that may have compromised device sterility. Affected devices were distributed nationwide 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: FDA Class II device with potential sterility compromise due to failed packaging testing; no reported illnesses or injuries to date. This meets the rubric criterion for risk-of-harm products where injury has not yet been reported, warranting High severity despite the absence of confirmed harm.

Plain-English summary

Cook Incorporated is recalling 35 units of the Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPWA-18-80, Order Number G56162), a medical device used for vascular catheter positioning and exchange in diagnostic and interventional procedures.

The recall was issued because the devices did not meet the FDA's acceptance criteria for packaging testing, specifically 3-year age acceleration testing. As a result, the sterility of the device may be compromised. Sterility is critical for medical devices to prevent infection in patients undergoing vascular procedures.

Affected devices were distributed nationwide and internationally to countries including Australia, Canada, Japan, and various European nations. The affected lot numbers are 14070920 and 14174878. Healthcare facilities and providers that received these devices should discontinue use immediately and contact Cook Incorporated for instructions on proper return or disposal.

The recalled product

Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-80 ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular / Interventional
Hazard
Affected units
35

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 (2)

  • UDI-DI: (01)00827002561625- Lot Numbers: 14070920
  • 14174878

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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