Medtronic Perfusion Systems: Medical Device Recall in 2017 - (Recall #: Z-2767-2017)
See the recall detail below. You can also see other recalls from the same firm in 2017.
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Class II
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Model No. 25009; Product UPN 20613994918608; Lot No. 2016090217, 2016091068, 2016100893, 2016110439, 2016120464, 2017010278, 2017030102, 2017030576, 2017031125. Model No. 25010: Product UPN 20613994918585: Lot No. 2016020841, 2016031522, 2016050255, 2016070494, 2016081243, 2016090923, 2016110054, 2016110837, 2017040714.
Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Austria, Belgium, Bulgaria, Canada, Croatia, Denmark, El Salvador, France, Georgia, Germany, Hungary, Ireland, Israel, Italy, Japan, Kuwait, Lebanon, Macedonia, Moldova, Netherlands, New Zealand, Nigeria, Norway, Poland, Romania, Russian Federation, Slovenia, Spain, Thailand, Turkey, & United Kingdom.
Voluntary: Firm initiated