Device product
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Z-2767-2017
Product summary
- Event
- Event 77641
- Status
- Terminated
- Classification
- Class II
- Quantity
- 63053 (48180 US) (14873 OUS)
- Official record key
device-enforcement:Z-2767-2017
Official wording
Reason: Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
Code information: 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.
Distribution pattern: 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.
Derived failure modes
-
Unknown
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.