FDAFDA · Food and drugs·Recall number Z-1552-2016
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Published May 4, 2016 · Recall initiated: March 29, 2016
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
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ev3, Inc.
- Distributor
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
- Lot
- A213373 and A216702
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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