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
- 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)00827002561526- Lot Numbers: 14118842
Distribution
Distributed nationwide across the United States.
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