Reported May 2, 2018 · Terminated
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Medtronic Vascular
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Vascular · 35-37A Cherry Hill Drive · Danvers, MA · 01923-2565
Is this the product you have?
Medtronic DxTerity Diagnostic CatheterJL 4.0REF DXT5JL40marked with 6F color code on box
- Lot codes and dates
UDI 20643169689309Lot Number 60074805
- Amount recalled
- 855 units
Why it was recalled
The color coded French size indicator on the outer box may incorrectly reflect a 6 French size, rather than the correct 5 French size. The catheters inside the carton are the correct DXT5JL40 item, the inner pouch has correct 5F labeling, information and configuration details.
This product could cause temporary or reversible health problems — stop using it.
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