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.
Reported: February 26, 2020 Initiated: January 29, 2020 #Z-1141-2020
Product Description
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.
Reason for Recall
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Details
- Recalling Firm
- Abbott Vascular
- Units Affected
- Total 791 Traveler (0 US and 791 OUS)
- Distribution
- Worldwide Distribution: US (Nation-wide) and OUS (countries of): Algeria Jordan Argentina Korea Armenia Kuwait Aruba Lebanon Australia Malaysia Austria, Mauritius Bahrain Mexico Bangladesh Morocco Belgium Netherlands Brazil New Zealand Brunei Norway Bulgaria Oman Canada Pakistan Chile Panama China Peru Colombia Poland Costa Rica Portugal Croatia R¿union Cyprus Romania Czech Republic Russian Federation Denmark Saudi Arabia Dominican Republic Singapore Egypt Slovakia Estonia Slovenia Finland South Africa France Spain Germany Sri Lanka Greece State of Palestine Hong Kong Sweden Hungary Switzerland Iceland Taiwan, Province of China India Thailand Indonesia Tunisia Iran Turkey Iraq Ukraine Ireland United Arab Emirates Israel United Kingdom Italy Uruguay Japan Viet Nam
- Location
- Temecula, CA
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Abbott Vascular. Units affected: Total 791 Traveler (0 US and 791 OUS).
Why was this product recalled? ▼
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2020. Severity: Critical. Recall number: Z-1141-2020.
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