Medtronic DxTerity Diagnostic Catheter recall: Labeling Error
Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
Why was Medtronic DxTerity Diagnostic Catheter 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 20643169689309, Lot Number 60074805
- Product
- Medtronic DxTerity Diagnostic Catheter, JL 4.0, REF DXT5JL40, marked with 6F color code on box.
- Recalling firm
- Medtronic Vascular
- Quantity
- 855 units
- Distribution
- US and AUSTRIA, Canada, Germany, ROMANIA, SLOVENIA,
- Recall date
- May 2, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)