| Class 2 Device Recall CS100 IntraAortic Balloon Pump. | |
Date Initiated by Firm | May 10, 2010 |
Date Posted | June 21, 2010 |
Recall Status1 |
Terminated 3 on October 27, 2010 |
Recall Number | Z-1811-2010 |
Recall Event ID |
55649 |
510(K)Number | K031636 |
Product Classification |
System, balloon, intra-aortic and control - Product Code DSP
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Product | CS100 Intra-Aortic Balloon Pump. |
Code Information |
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. |
Recalling Firm/ Manufacturer |
Datascope Corporation 15 Law Dr Fairfield NJ 07004-0011
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For Additional Information Contact | Kevin Crossen 973-244-6100 |
Manufacturer 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 2 | Other |
Action | 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. |
Quantity in Commerce | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DSP
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