Medtronic Vascular: Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

Is my product affected?

Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.

• UPC 20643169689309

Check against the official notice below — it lists the full affected range.

What happened

Medtronic is recalling Medtronic DxTerity Diagnostic Catheter, JL 4.0 (model DXT5JL40) with a 6F color code on the box. The outer box label incorrectly indicates a 6 French size rather than the correct 5 French size. However, the actual catheters inside the carton are correct 5 French size devices, and the inner pouch contains proper 5F labeling with correct information and configuration details. A total of 855 units were distributed to the United States, Austria, Canada, Germany, Romania, and Slovenia, with lot number 60074805 and UDI 20643169689309.

The recall notice does not specify a remedy or action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA, Quantity: 855 units Lot/code info: UDI 20643169689309, Lot Number 60074805

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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