The Recall Desk
HighFDA (Devices)·Z-1840-2022·Announced 2022-10-05

Cook Roadrunner PC Guidewire Recalled for Compromised Packaging Seal

Cook Incorporated recalls Roadrunner PC Wire Guide devices due to a potential packaging seal breach that may compromise sterility. The recall affects 115 units distributed domestically and 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 a Class II medical device recall involving a potential compromise of device sterility from a packaging seal defect. No illnesses or injuries have been reported. This constitutes a risk-of-harm product without reported injury, meeting the criterion for High (3) severity.

Plain-English summary

Cook Incorporated has recalled Roadrunner PC Wire Guide (The Firm LT) devices, model RLPC-35-145 (UDI-DI: 00827002068667). The recall affects 115 units.

Cook Medical identified that devices from the affected lots may have a complete breach of the chevron seal of the packaging, which may compromise the sterility of the devices. The affected lots are 14828631, 14828643, and 14828644, all with an expiration date of June 7, 2025.

The devices were distributed domestically throughout the United States and internationally worldwide. Healthcare providers and patients who may have received these devices should contact Cook Incorporated for identification and handling instructions regarding the affected units.

The recalled product

Product
Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN RLPC-35-145 G06866
Manufacturer
Cook Incorporated
Category
Medical Device — Surgical Guidewire
Hazard
  • packaging-seal-breach
  • sterility-compromise

Distribution

Distributed nationwide across the United States.

Related recalls

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