The Recall Desk
HighFDA (Devices)·Z-1828-2022·Announced 2022-10-05

Coons Interventional Guidewire Recall Due to Packaging Sterility Breach

Cook Incorporated is recalling Coons Interventional Wire Guide devices because the chevron seal on packaging may be completely breached, compromising sterility. 1,236 units were distributed.

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 with potential sterility compromise from packaging defect. Guidewires are invasive devices where compromised sterility poses infection risk. No illnesses or injuries reported; the hazard is theoretical.

Plain-English summary

Cook Incorporated is recalling Coons Interventional Wire Guide devices, which are sterile medical devices used in interventional procedures. The recalled devices include multiple reference part numbers and lot codes distributed domestically and worldwide.

Cook Medical identified that the chevron seal on the packaging of affected devices may be completely breached. A breached seal can compromise the sterility of the medical device.

Users of affected products should stop using them immediately. Healthcare providers who have received these devices should identify the affected lot codes from their inventory and cease use. Patients should inform their healthcare providers if they have received a procedure using an affected device. Contact Cook Incorporated or the FDA for more information.

The recalled product

Product
Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF-35-145-COONS G02356 THSF-38-145-COONS G02324 THSF-35-180-COONS G02621 THSF-35-80-COONS G12268
Manufacturer
Cook Incorporated
Category
Medical Device — Interventional Guidewire
Hazard
  • sterility-compromise
  • contamination-risk

Distribution

Distributed nationwide across the United States.

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