Z-2767-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- August 2, 2017
- Initiation Date
- June 22, 2017
- Termination Date
- July 22, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 63053 (48180 US) (14873 OUS)
Product Description
DLP Pressure Monitoring Extension Line Adapters Extends the pressure line in order to reach the pressure monitoring unit during cardiopulmonary bypass surgery.
Reason for Recall
Identification of small pinholes in a single packaging configuration of sterile pouches. A total of seven different products were affected.
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.
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.