Recall Z-1552-2016
ev3, Inc. · initiated March 29, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
Codes / lots: A213373 and A216702
Reason for recall
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.
FDA-determined cause: Labeling False and Misleading
Action taken
Consignees were sent on 3/29/2016 a Medtronic "Urgent Medical Device Recall" letter dated March 2016. The letter was addressed to Risk Manger or Health Care Professional. The letter described the problem and the product involved in the recall.
Details
- Recall number
- Z-1552-2016
- Initiated
- March 29, 2016
- Posted by FDA
- April 22, 2016
- Terminated
- May 19, 2017
- Product code
- LIT – Catheter, Angioplasty, Peripheral, Transluminal
- Quantity
- 27 (25 US, 2 OUS)
- Distribution
- US: CA, GA, LA, MI, MS, MO,NV,NH. NY, OH, PA, SD, TX. OUS: SINGAPORE
- Recalling firm
- ev3, Inc., Minneapolis, MN