Roadrunner UniGlide wire guide recalled for potential sterility compromise
Cook Incorporated is recalling 189 Roadrunner UniGlide hydrophilic wire guides because they failed packaging testing requirements and their sterility may be compromised.
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 with potential sterility compromise due to failed packaging testing. No reported illnesses, injuries, or confirmed sterility breach. This qualifies as a risk-of-harm product where injury has not yet been reported, consistent with the High severity threshold.
Plain-English summary
Cook Incorporated has recalled 189 units of the Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPWAS-35-80, Order Number G56175). These devices are used in diagnostic and interventional vascular procedures to position and exchange catheters.
The recall was issued because these devices did not meet acceptance criteria for packaging testing, which included 3-year age acceleration testing. Consequently, the sterility of the recalled devices may be compromised. The affected lot numbers are 14174876, 14174880, NS14104906, NS14173970, and NS14173971.
The recalled devices were distributed nationwide in the United States and internationally to Argentina, Austria, Australia, Belgium, Bulgaria, Canada, Switzerland, Chile, China, Czech Republic, Germany, Denmark, Spain, France, the United Kingdom, Greece, Guam, Hungary, Israel, Italy, Jordan, Japan, South Korea, Kuwait, Mexico, Malaysia, New Caledonia, the Netherlands, Peru, Poland, Puerto Rico, Portugal, Paraguay, Russia, Sweden, Slovenia, Turkey, Uruguay, and South Africa.
The recalled product
- Product
- Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPWAS-35-80 ORDER NUMBER (GPN): G56175. 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 (5)
- UDI-DI: (01)00827002561755- Lot Numbers: 14174876
- 14174880
- NS14104906
- NS14173970
- NS14173971
Distribution
Distributed nationwide across the United States.
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