Recall Z-1198-2009
Datascope Corporation · initiated February 4, 2009
Product
Low-Level Output Cable. The device is used to allow the information displayed on the Intra-aortic balloon pump (IABP) to be displayed on a separate patient monitor.
Codes / lots: Part Number: 0012-00-1589-03 Rev. C, RAM 0827.
Reason for recall
Non-functioning cable: the Low-Level Output Cable when connected to a Datascope Intra-aortic Ballon Pump (IABP) and patient monitor does not provide a signal to the patient monitor.
FDA-determined cause: Process design
Action taken
An "Urgent Medical Device Recall" letter dated February 4, 2009 was delivered to affected consignees by Datascope Field Representatives. Direct questions to your local Sales/Service Representative or call the Datascope Corporation at 1-973-244-6314.
Details
- Recall number
- Z-1198-2009
- Initiated
- February 4, 2009
- Posted by FDA
- April 15, 2009
- Terminated
- August 11, 2009
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 20
- Distribution
- Nationwide Distribution -- states of IL and FL.
- Recalling firm
- Datascope Corporation, Fairfield, NJ