FDAFDA · Food and drugs·Recall number Z-1489-2014
ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 120mm x 135cm, REF: AB35W06120135. and ev3 EverCross 0.035" OTW PTA Dilatation Catheter, 6mm x 40mm x, 80cm REF: AB35W06040080. Peripheral Dilatation Catheter
Published April 30, 2014 · Recall initiated: April 9, 2014
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
Covidien is recalling 2 production lots of EverCross 0.035 PTA Balloon Catheter because of a product labeling error. There is a discrepancy in the PTA Balloon length and the delivery catheter length printed on the product labeling.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Ev3, Inc.
- Distributor
- Worldwide Distribution-USA including the states of WV, TX, OK, IN, NY, TX, and NC, and the countries of AUSTRALIA, ISRAEL, TURKEY, UNITED KINGDOM, ITALY, FRANCE, and CHINA.
- Lot
- AB35W06120135 Lot: 9855406 Use by: 2017-01-16 AB35W06040080 Lot: 9852591 Use by: 2017-01-16
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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