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U.S. Department of Health and Human Services

Class 2 Device Recall Anestar

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 Class 2 Device Recall Anestarsee related information
Date Initiated by FirmJune 24, 2003
Date PostedSeptember 09, 2004
Recall Status1 Terminated 3 on October 03, 2006
Recall NumberZ-1441-04
Recall Event ID 29545
Product Classification Gas-Machine, Anesthesia - Product Code BSZ
ProductAnestar Anesthesia Delivery System
Code Information Serial#: 4600010001; 4600010003; 4600010004; 4600010007; 4600010008; 4600010009; 4600010010; 4600010012; 4600A20017; 4600A20018; 4600A20019; 4600A20020; 4600A20021; 4600A20023; 4600A20024; 4600A30066; 4600A30067; 4600A30068; 4600A30069; 4600A30070; 4600A30071; 4600A30072; 4600A30073; 4600A30074; 4600A30075; 4600B10002; 4600B20025; 4600B20026; 4600B20027; 4600B20028; 4600B20029; 4600B20030; 4600B20031; 4600B20032; 4600B20033; 4600B20034; 4600B30076; 4600B30077; 4600B30078; 4600B30079; 4600B30080; 4600B30081; 4600B30082; 4600B30083; 4600B30084; 4600B30086; 4600C30087; 4600C30088; 4600C30089; 4600C30091; 4600C30092; 4600C30093; 4600C30094; 4600C30095; 4600C30096; 4600C30097; 4600C30098; 4600C30099; 4600D20035; 4600D20036; 4600D20037; 4600D20038; 4600D20039; 4600D20040; 4600D20041; 4600D20042; 4600D20043; 4600D20044; 4600H20045; 4600H20046; 4600H20047; 4600H20048; 4600H20049; 4600H20050; 4600H20051; 4600H20052; 4600H20053; 4600H20054; 4600I10013; 4600J20055; 4600J20056; 4600J20057; 4600J20058; 4600J20059; 4600J20060; 4600J20061; 4600J20062; 4600J20063; 4600J20064.
Recalling Firm/
Manufacturer		 Datascope Corp
800 MacArthur Blvd
Mahwah NJ 07430-0619
For Additional Information ContactSusan E. Mandy
201-995-8025
Manufacturer Reason
for Recall		Failure of the Anestar AC Main Power Switch. Battery should last 30 minutes, then ventilation and monitoring will fail.
FDA Determined
Cause 2		Other
ActionA Field Correction action was initiated in June, 2003 and completed by the service reps in April, 2004.
DistributionThe units were distributed to 29 hospitals nationwide. There are no US Government military or civilian customers.
Total Product Life CycleTPLC Device Report
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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