FDAFDA · Food and drugs·Recall number Z-1143-2020
NC TRAVELER Coronary Dilatation Catheter, REF 1013158-08, Rx Only,NC Traveler RX 4.5 X 8MM The NC Traveler RX Coronary Dilatation Catheter is not cleared for commercial distribution in the United States.
Published February 26, 2020 · Recall initiated: January 29, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Coronary Dilatation Catheters may exhibit difficulty or inability to deflate the balloon.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Abbott Vascular
- Distributor
- 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
- Lot
- Device Identifier/GTIN: 08717648196027 Part Number: 1013158-08 Lot Numbers:90812G1
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
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