Cook Roadrunner Guidewire Recalled for Compromised Sterile Packaging Seal
Cook Incorporated is recalling Roadrunner PC Wire Guide guidewires due to a complete breach of the sterile packaging seal. The breach may compromise device sterility, affecting 202 units in the US and 11 internationally.
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: This is an FDA Class II medical device recall involving potential sterility compromise due to packaging seal breach. No illnesses or injuries have been reported, and the hazard is theoretical rather than confirmed, placing it under the rubric criterion of risk-of-harm products without demonstrated injury.
Plain-English summary
Cook Incorporated is recalling certain Roadrunner PC Wire Guide (RFPC-35-145, G07914) guidewires due to a packaging defect. These are sterile medical guidewires intended for interventional procedures.
The affected devices have a complete breach of the chevron seal of the sterile packaging. This breach may compromise the sterility of the devices. Cook Incorporated identified this issue and initiated the recall.
The recall affects 202 units distributed in the United States and 11 units distributed internationally. The affected lot numbers are 14828624, 14828638, 14837046, and NS14828650. Expiration dates for these lots range from 06-07-2025 to 12-07-2025. Distribution was nationwide in the US and worldwide internationally.
Healthcare providers and patients who have these devices should contact Cook Incorporated regarding their options. Do not use any device with compromised packaging integrity.
The recalled product
- Product
- Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
- packaging-defect
Distribution
Distributed nationwide across the United States.
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