ev3 product recalled over labeling errors
- Recall date
- March 29, 2016
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- ev3, Inc. recalls ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
- Recall number
- Z-1552-2016
- FDA classification
- Class II
- Brand / firm
- ev3, Inc.
- Sold / distributed
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
Why it was recalled
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
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