Vascular Catheter Wire Guide Recalled for Possible Sterility Compromise
Cook Incorporated is recalling 585 Roadrunner UniGlide Hydrophilic Wire Guides because they failed packaging sterility tests, potentially compromising device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 failed sterility testing but no reported illnesses or injuries. The potential compromise of sterility in a vascular catheter positioning device—a risk-of-harm medical product—warrants High severity per the rubric.
Plain-English summary
Cook Incorporated is recalling the Roadrunner UniGlide Hydrophilic Wire Guide (Reference Part Number HPW-35-150, Order Number G56149), used for vascular catheter positioning and exchange in diagnostic and interventional medical procedures.
The recall affects 585 units distributed nationwide and internationally. The affected lot numbers are: 14070921, 14108915, 14108916, 14129152, 14141997, and 14170230. The device was recalled because it did not meet acceptance criteria for packaging testing, including 3-year age acceleration testing, which means the sterility of the device may be compromised.
The recalled product
- Product
- Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HPW-35-150 ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Affected units
- 585
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 (6)
- UDI-DI: (01)00827002561496- Lot Numbers: 14070921
- 14108915
- 14108916
- 14129152
- 14141997
- 14170230
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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