Roadrunner PC Hydrophilic Wire Guide Recalled Due to Sterility Compromise
Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure that may compromise sterility. No illnesses have been reported.
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: This is a Class II medical device with potential sterility compromise—a risk-of-harm product where serious infection could result from non-sterile conditions during vascular interventions. However, no illnesses or injuries have been reported and the hazard is theoretical, placing it at the High severity level per the rubric.
Plain-English summary
Cook Incorporated is recalling 496 units of the Roadrunner PC Hydrophilic Wire Guide (Reference Part Number RFPC-35-180, Order Number G07937). This device is used during vascular catheter positioning and exchange in diagnostic and interventional procedures.
The recall was initiated because the product did not meet acceptance criteria for 3-year age acceleration testing during packaging validation. This failure indicates that the sterile barrier of the device may be compromised, potentially affecting sterility assurance.
The affected lot numbers are 14145420, 14145424, 14156909, 14156912, 14156916, 14164348, and 14173577. These units were distributed nationwide and internationally. No illnesses or injuries have been reported in connection with this issue.
The recalled product
- Product
- Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-180 ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Affected units
- 496
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 (7)
- UDI-DI: (01)00827002079373- Lot Numbers: 14145420
- 14145424
- 14156909
- 14156912
- 14156916
- 14164348
- 14173577
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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