Vascular catheter wire guide recalled for sterility testing failure
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides due to packaging testing failures that may compromise device sterility. The recall affects 865 units 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: This Class II medical device recall involves compromised sterility from failed packaging testing. Although no illnesses or injuries have been reported, compromised sterility in a vascular catheter device qualifies as a risk-of-harm product where injury has not yet occurred, per the severity rubric.
Plain-English summary
Cook Incorporated is recalling Roadrunner UniGlide Hydrophilic Wire Guides (Reference Part Number HPWAS-35-150, Order Number G56176). These devices are used for vascular catheter positioning and exchange in diagnostic and interventional procedures.
The devices failed to meet acceptance criteria for packaging testing, including 3-year age acceleration testing. The company determined that sterility of the device may be compromised as a result.
The recall involves 865 units with the following lot numbers: 14112845, NS14062106, NS14080814, NS14089120, NS14118843, NS14139358, NS14142006, NS14144747, NS14148490, NS14149799, NS14153797, NS14172915. These devices were distributed nationwide and to multiple countries internationally.
The recalled product
- Product
- Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-150 ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
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 (12)
- UDI-DI: (01)00827002561762- Lot Numbers: 14112845
- NS14062106
- NS14080814
- NS14089120
- NS14118843
- NS14139358
- NS14142006
- NS14144747
- NS14148490
- NS14149799
- NS14153797
- NS14172915
Distribution
Distributed nationwide across the United States.
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