The Recall Desk
HighFDA (Devices)·Z-1841-2022·Announced 2022-10-05

Roadrunner PC Wire Guide Recalled for Packaging Breach and Sterility Compromise

Cook Incorporated recalls Roadrunner PC Wire Guide devices due to packaging seal breaches that may compromise sterility. Devices were distributed nationwide 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 an FDA Class II recall involving potential sterility compromise of medical devices used in surgical procedures. While no illnesses or injuries have been reported, sterility compromise of medical devices represents a high-risk-of-harm situation where injury has not yet been reported, meeting Score 3 criteria.

Plain-English summary

Cook Incorporated is recalling Roadrunner PC Wire Guide devices (Reference Part Numbers RPC-35-145 and RPC-35-80) due to a packaging integrity issue identified in affected device lots.

The manufacturer identified that affected devices may have a complete breach of the chevron seal of the packaging. This breach may compromise the sterility of the devices, which is critical for safe use in medical applications.

A total of 363 units were distributed in the United States and 244 units were distributed internationally. The devices were distributed nationwide domestically and worldwide internationally.

Healthcare providers should contact Cook Incorporated for guidance on affected lot numbers, expiration dates, return procedures, and replacement options.

The recalled product

Product
Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RPC-35-145 G06979 RPC-35-80 G09534
Manufacturer
Cook Incorporated
Category
Medical Device — Guidewire
Hazard
  • sterility-compromise
  • packaging-defect

Distribution

Distributed nationwide across the United States.

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