The Recall Desk
HighFDA (Devices)·Z-1838-2022·Announced 2022-10-05

FDA Recalls Cook Roadrunner PC Wire Guides for Packaging Sterility Breach

Cook Incorporated is recalling Roadrunner PC Wire Guide devices due to a breach in packaging's chevron seal that may compromise sterility. Affected devices should not be used.

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 Class II guidewire recall with sterility-compromising packaging defect poses significant infection risk in invasive medical procedures. No injuries or illnesses reported, but per rubric criteria for risk-of-harm products without reported injury, severity is High (3).

Plain-English summary

Cook Incorporated is recalling specific lots of the Roadrunner PC Wire Guide (Nimble), a guidewire medical device used in interventional procedures. The recall affects 277 units distributed in the United States and 138 units distributed internationally.

The devices are being recalled because the packaging's chevron seal may be completely breached in affected units, which compromises the sterility of the device. Sterile packaging is critical for medical devices used in invasive procedures to prevent infection.

Affected lot numbers are: 14831437, 14831438, 14835040, 14840287, 14840288, and 14840309. Healthcare providers and patients who have these devices should not use them. Contact Cook Incorporated or your healthcare provider for guidance on replacement or return of affected devices.

The recalled product

Product
Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFSPC-35-145 G09607
Manufacturer
Cook Incorporated
Category
Medical Device — Cardiovascular / Interventional
Hazard
  • sterility-compromise
  • packaging-defect

Distribution

Distributed nationwide across the United States.

Related recalls

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