Roadrunner PC Hydrophilic Wire Guide Recalled Due to Packaging Integrity Failure
Cook Incorporated is recalling 2,407 units of Roadrunner PC Hydrophilic Wire Guide due to failed packaging integrity testing that may compromise device sterility. No illnesses or injuries have been reported.
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 classified this as a Class II device. No illnesses or injuries have been reported. The hazard is theoretical based on failed packaging acceptance criteria, fitting the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cook Incorporated is recalling 2,407 units of the Roadrunner PC Hydrophilic Wire Guide (Reference Part Number RFSPC-35-180, Order Number G09608), used for vascular catheter positioning and exchange in diagnostic and interventional procedures.
The device did not meet acceptance criteria for packaging integrity testing, which included 3-year age acceleration testing. This failure means the sterility of the device may be compromised, creating a potential safety risk for patients.
The recalled product includes 14 specific lot numbers: 14071906, 14091204, 14134663, 14134667, 14134669, 14134670, 14134673, 14134676, 14143872, 14143873, 14160997, 14184102, NS14143735, and NS14152903. The product has been distributed nationwide and internationally to multiple countries.
Healthcare providers should contact Cook Incorporated regarding recalled lots and for further guidance on managing inventory and patient safety.
The recalled product
- Product
- Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35-180 ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Vascular Device
- Hazard
- sterility-failure
- contamination-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 (14)
- UDI-DI: (01)00827002096080- Lot Numbers: 14071906
- 14091204
- 14134663
- 14134667
- 14134669
- 14134670
- 14134673
- 14134676
- 14143872
- 14143873
- 14160997
- 14184102
- NS14143735
- NS14152903
Distribution
Distributed nationwide across the United States.
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