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Medtronic Perfusion Systems recalls DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring uni
Recalled August 2, 2017 · FDA recall Z-2767-2017 · Medtronic Perfusion Systems
Hazard
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected. · FDA Class II
Units
63053 (48180 US) (14873 OUS)
Sold at
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.
Description
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Product
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →