Vascular wire guides recalled due to potential sterility compromise
Cook Incorporated is recalling 5,400 Roadrunner UniGlide Hydrophilic Wire Guides because the devices failed packaging tests required to verify sterility. The affected devices are used in diagnostic and interventional vascular procedures.
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—a critical property for devices used in vascular procedures—may be compromised due to failed packaging testing. Although no illnesses or injuries have been reported and the risk is theoretical, the potential harm from non-sterile vascular catheters in clinical use meets the rubric for High severity.
Plain-English summary
The Roadrunner UniGlide Hydrophilic Wire Guide is a medical device used for positioning and exchanging vascular catheters during diagnostic and interventional procedures. Cook Incorporated is recalling 5,400 units due to packaging test failures.
The devices did not meet acceptance criteria for packaging testing, including 3-year age acceleration testing. Because of this failure, the sterility of the affected devices may be compromised.
The recalled devices were distributed nationwide and internationally. Customers in possession of affected lot numbers should stop using the devices and contact Cook Incorporated for return and replacement instructions.
The recalled product
- Product
- Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-35-150 ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Hazard
- Affected units
- 5,400
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 (20)
- UDI-DI: (01)00827002561731- Lot Numbers: 14070910
- 14070913
- 14070914
- 14070915
- 14070916
- 14070917
- 14080810
- 14104898
- 14104899
- 14104902
- 14106628
- 14106629
- 14120473
- 14120474
- 14120475
- 14122089
- 14122091
- 14122093
- 14122095
- 14122322
Distribution
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.
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