The Recall Desk
HighFDA (Devices)·Z-1717-2022·Announced 2022-09-21

Roadrunner UniGlide Vascular Wire Guide Recalled for Sterility Compromise

Cook Incorporated is recalling 30 units of Roadrunner UniGlide Hydrophilic Wire Guides due to packaging failure that may compromise device sterility.

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 where packaging integrity failure could compromise sterility. While no illnesses or injuries have been reported, the potential for serious infection in vascular procedures classifies this as a risk-of-harm product at High severity per the rubric.

Plain-English summary

Cook Incorporated is recalling 30 units of the Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPWS-35-150, Order Number G56152), a medical device used for vascular catheter positioning and exchange in diagnostic and interventional procedures.

The affected lot number is 14118842. The devices were distributed in the United States and internationally.

The recall was initiated because the devices did not meet acceptance criteria for packaging testing, specifically 3-year age acceleration testing. Cook Incorporated states that this failure means the sterility of the device may be compromised.

Healthcare facilities and distributors with the affected lot number should contact Cook Incorporated for guidance on handling and disposal of the affected devices.

The recalled product

Product
Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWS-35-150 ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular Access Device
Hazard
Affected units
30

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)00827002561526- Lot Numbers: 14118842

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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