Z-2766-2017 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 Cardioplegia Adapter with Pressure Port Provides access for a pressure monitoring needle near the connection to the cardioplegia cannula. These adapters are intended for use in conjunction with the delivery of cardioplegia solution and to provide access for pressure monitoring for up to six hours
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. 15004; Product UPN 20613994900412; Lot No. 2016031072, 2016031509, 2016050243, 2016081219, 2016100630, 2016120083, 2016120448, 2017040113.