Vascular Wire Guide Recalled for Potential Sterility Compromise
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide due to failed packaging testing that may compromise device sterility. The affected lot numbers are 14095646 and 14174879.
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 illnesses or injuries have been reported; the hazard is theoretical. This rating reflects the high-risk nature of a compromised sterile medical device used in vascular procedures, but without confirmed adverse events.
Plain-English summary
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide (reference part number HPWA-18-150) used for vascular catheter positioning and exchange in diagnostic and interventional procedures.
The devices did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing. Because of this failure, the sterility of the affected devices may be compromised.
Approximately 85 units were distributed with lot numbers 14095646 and 14174879 to facilities nationwide and in multiple countries internationally.
Consumers and healthcare providers who possess these devices should contact Cook Incorporated for instructions on the recall.
The recalled product
- Product
- Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWA-18-150 ORDER NUMBER (GPN):G56161. 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 (2)
- UDI-DI: (01)00827002561618- Lot Numbers: 14095646
- 14174879
Distribution
Distributed nationwide across the United States.
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