Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Reported: May 2, 2018 Initiated: March 13, 2018 #Z-1479-2018
Product Description
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
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.
Details
- Recalling Firm
- Medtronic Vascular
- Units Affected
- 855 units
- Distribution
- US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
- Location
- Danvers, MA
Frequently Asked Questions
What product was recalled? ▼
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.. Recalled by Medtronic Vascular. Units affected: 855 units.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 2, 2018. Severity: Moderate. Recall number: Z-1479-2018.
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