Cook Roadrunner PC Guidewires Recalled for Compromised Packaging Sterility
Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires due to potential packaging seal breaches that may compromise device sterility. Affected devices were distributed in the United States and internationally.
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 risk-of-harm product (sterile surgical guidewire) where packaging seal breach could compromise sterility. The recall notice does not report any illnesses or injuries. The hazard is theoretical (sterility 'may be' compromised), meeting the rubric criterion for High severity: risk-of-harm products where injury has not been reported.
Plain-English summary
Cook Incorporated is recalling Roadrunner PC Hydrophilic Guidewires because the chevron seal of the packaging may be completely breached, potentially compromising the sterility of the affected devices.
The recall affects devices distributed in the United States (56 units) and internationally (1,033 units). Affected devices carry multiple reference part numbers with associated lot numbers and expiration dates ranging from June through July 2025.
The recalled product
- Product
- Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part Number/GPN: RPC-035145-0-5 G34131 RPC-035145 G18154 RPC-035145-5 G34132 RPC-038145-0-5 G34129 RFSPC-038145-0 G17539 RFSPC-035145 G17540 RPC-038145-0 G18155 RPC-035145-0 G18153 RFSPC-035145-0…
- Manufacturer
- Cook Incorporated
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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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