Cook Medical Wire Guide Devices Recalled for Packaging Breach
Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices due to a complete breach of the packaging chevron seal, which may compromise sterility.
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 a sterility compromise on an invasive medical device. No illnesses or injuries have been reported. The potential for serious infection from non-sterile invasive devices is high-risk, but without reported adverse events, the score is severity level 3 per the rubric.
Plain-English summary
Cook Incorporated is recalling specific lots of Double Flexible Tipped Wire Guide Guidewire devices used in surgical and interventional procedures to guide catheters and other instruments inside the body.
The company identified that the packaging on affected device lots has a complete breach of the chevron seal that maintains sterility. This breach may compromise the sterility of the devices, creating a risk of infection if the non-sterile devices are used in patient procedures.
Approximately 150 units were distributed in the United States and 97 units internationally. Healthcare providers should check whether they have inventory matching the recalled lot numbers and expiration dates, and follow Cook Incorporated's and the FDA's guidance on handling and patient notification.
The recalled product
- Product
- Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
- packaging-breach
Distribution
Distributed nationwide across the United States.
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