Cook Inc. Recalls Roadrunner Hydrophilic PC Wire Guides Due to Loading Error
Cook Inc. is recalling Roadrunner Hydrophilic PC Wire Guides because they may be incorrectly loaded, causing the stiff tip to be introduced into patients instead of the flexible tip.
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: The recall involves a medical device defect that poses a risk of harm to patients by introducing a stiff tip instead of a flexible one, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Cook Inc. is recalling Roadrunner Hydrophilic PC Wire Guides, identified by Global Product Numbers G18629 and G17866. The recall involves 13,388 units that were distributed domestically across the United States and internationally to numerous countries, including Australia, Canada, China, France, Germany, India, Japan, and the United Kingdom.
The recall was initiated because the wire guide may be incorrectly loaded into the wire guide holder. This error can lead to the stiff tip of the wire guide being introduced into the patient instead of the intended flexible tip.
Healthcare providers and facilities should stop using the affected wire guides and contact Cook Inc. for further instructions on the recall process.
The recalled product
- Product
- Roadrunner Hydrophilic PC Wire Guide, Guidewire, Global Product Number G18629, G17866
- Manufacturer
- Cook Inc.
- Affected units
- 13,388
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 recalled by Cook Inc. 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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