Recall Z-1811-2010
Datascope Corporation · initiated May 10, 2010
Product
CS100 Intra-Aortic Balloon Pump.
Codes / lots: Product number 0998-00-3023-XX: SA122365C8 SA122373C8. International: SA122359C8 SA122375C8 SA122358C8 SA122360C8 SA122363C8 SA122362C8 SA122361C8 SA122368C8 SA147699K8 SA122366C8 SA122370C8 SA119292B8 SA122371C8 SA122364C8 SA122367C8 SA122369C8 SA122372C8.
Reason for recall
Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related issues. Although the IABP continues to deliver therapy to the patient, display related issues may cause the user to be unable to view the IABP on the information screen.
FDA-determined cause: Other
Action taken
Medical Device Recall Letters were sent to Hospital Administrators beginning May 10, 2010 by overnight mail. Customers with questions are directed to contact your local Sales/Service Representative or the company representative at 973-244-6314.
Details
- Recall number
- Z-1811-2010
- Initiated
- May 10, 2010
- Posted by FDA
- June 21, 2010
- Terminated
- October 27, 2010
- Product code
- DSP – System, Balloon, Intra-Aortic And Control
- Quantity
- 161 total devices
- Distribution
- Class 2 - Worldwide distribution -- US and Distribution to Australia, Belarus, Belgium, Canada, Egypt, England, Germany, Hong Kong, India, Iran, Israel, Japan, Kuwait, Latvia, Lebanon, Serbia, Singapore, Spain, Switzerland, Turkey, Venezuela.
- Recalling firm
- Datascope Corporation, Fairfield, NJ
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1812-2010 | CS300 Intra-Aortic Balloon PumpCertain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related… | 05/10/2010Terminated |
| Z-1813-2010 | System 98XT/98 Intra-Aortic Balloon Pump This product was only distributed in India and…Certain MAQUET/Datascope Intra-Aortic Balloon Pumps (IABP) have the potential to experience display related… | 05/10/2010Terminated |