NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Enforcement
- Recall Number
- Z-1140-2020
- Event ID
- 84826
- Classification
- Class I
- Status
- Terminated
- Product Type
- Devices
- Firm
- Abbott Vascular
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- February 26, 2020
- Initiation Date
- January 29, 2020
- Classification Date
- February 14, 2020
- Termination Date
- April 16, 2024
- Address
- 26531 Ynez Rd, D-03Q3, AP52-1, Temecula, CA, 92591-4630, United States
Description
NC TRAVELER Coronary Dilatation Catheter, REF 1013157-08, Rx Only,NC Traveler RX 4.0 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
Device Identifier/GTIN: 08717648195983 Part Number: 1013157-08 Lot Numbers:91010G1
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
Total 791 Traveler (0 US and 791 OUS)