The Recall Desk
HighFDA (Devices)·Z-1709-2022·Announced 2022-09-21

Roadrunner PC Wire Guide Recalled for Sterility Testing Failure

Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide due to packaging failure in sterility testing. The device's sterility may be compromised.

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 medical device recall for potential sterility compromise due to packaging failure. With no reported illnesses or injuries in the source text and a potential rather than confirmed hazard, this meets the threshold for High (score 3) rather than Severe (score 4) per the rubric.

Plain-English summary

Cook Incorporated is recalling 1,997 units of the Roadrunner PC Hydrophilic Wire Guide (Reference Part Number RPC-35-180), a device used for vascular catheter positioning and exchange in diagnostic and interventional procedures. The recall was initiated because the product did not meet acceptance criteria for packaging integrity testing, which included 3-year age acceleration testing. As a result, the sterile packaging may have deteriorated, potentially compromising the device's sterility.

The affected devices were distributed nationwide and internationally, including multiple countries across Europe, Asia, Middle East, Africa, and the Americas. The recall affects devices with lot numbers 14063361, 14087089, 14087092, 14117033, 14120926, 14120928, 14151216, 14151218, 14153159, 14158614, 14159695, and 14159696.

The recalled product

Product
Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RPC-35-180 ORDER NUMBER (GPN):G07518. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular Interventional Device
Hazard
Affected units
1,997

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 (12)

  • UDI-DI: (01)00827002075184 Lot Numbers: 14063361
  • 14087089
  • 14087092
  • 14117033
  • 14120926
  • 14120928
  • 14151216
  • 14151218
  • 14153159
  • 14158614
  • 14159695
  • 14159696

Distribution

Distributed nationwide across the United States.

The notice also names 7 states specifically:

Part of a larger recall action

This product is one of 13 recalled by Cook Incorporated 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.

See all 13 products in this recall →

Related recalls

Same manufacturer · Cook Incorporated

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Same hazard · sterility compromise

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