Reported Feb 26, 2020 · Terminated
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary…
Abbott Vascular
High riskUsing this product could cause serious injury, illness or death — stop using it now.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: Abbott Vascular · 26531 Ynez Rd · Temecula, CA · 92591-4630
Is this the product you have?
- NC TRAVELER Coronary Dilatation Catheter, REF 1013157-12, Rx Only,NC Traveler RX 4.0 X 12MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
- Lot codes and dates
- Device Identifier/GTIN08717648195990
- Part Number1013157-12
- Lot Numbers90812G1
- Amount recalled
- Total 791 Traveler (0 US and 791 OUS)
This recall covers 17 products
The agency filed one notice per product. You are reading one of them; the other 16 are below.
4 more are in the archive.
Why it was recalled
Stop using this product now
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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