Events

Recall of Device Recall Anestar

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Datascope Corp.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    35059
  • Event Risk Class
    Class 2
  • Event Number
    Z-0929-06
  • Event Initiated Date
    2006-03-17
  • Event Date Posted
    2006-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-08-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45203
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Gas-Machine, Anesthesia - Product Code BSZ
  • Reason
    The anestar and anestar plus anesthesia system may produce periods of high positive end-expiratory pressure (peep), in both manual and mechanical ventilation mode due to an issue with the applied pressure limit (apl) valve.
  • Action
    Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.

Device

Device Recall Anestar
  • Model / Serial
    Serial Numbers starting with 4600: A51083; C51104; C51116; C51117; C51120; C51121; C51125; E41025; G30143; L41062; L41063; L41064; L41065; L41071; L41075; 010001; 010002; 010008; 010010; A20024; A51076; A51077; A51078; A51081; A51084; B20027; B30076; B30077; B30078; B30081; B30082; B30083; B41005; B51087; B51088; B51089; B51092; B51096; C30087; C30092; C30093; C30094; C30095; C30096; C30097; C30098; C30099; C30102; C41014; C41015; C41017; C41020; C51114; C51118; D20035; D20036; D20037; D20038; D20042; D20043; D20044; D30100; D30101; D30103; D30104; D30105; D30106; D30107; D30108; D30109; E30112; E30113; E30115; E30116; E30117; E30118; E41029; F30120; F30128; F30129; F30131; F30132; F30133; F30134; F30135; G30136; G30137; G30138; G30139; G30140; G30142; H20045; H20047; H20051; H20052; I10010; I41031; I41035; I41036; I41038; I41041; I41042; I41043; I41044; I41045; I41046; I41047; I41048; I41049; I41050; J20055; J20056; J20057; J20059; J20060; J20061; J20063; J20064; K41057; L41066; L41073; A20018; A20023; A30069; A30070; B20026; B20028; B20030; B30084; B30086; C41031; C41018; D20014; I41034; I41037; K41060; L30162; L41068; C51101; C51103; C51111; C51113; D51131; F30122US; F30127; H30149; I41033; I41039; I41040; 010007; E30114; H30144; H30145; H30146; H30147; H30148; H30150; H30151; H30152; H30153; H30155; A30066; A30067; A30071; A51080; A51082; A51085; B41002; B51086; B51090; B51097; C41011; C41061; C41091; C51105; C51108; C51115; C51123; D51127; D51129; D51132; D51135; E41022; E41023; E41024; E41026; F30130; H20048; I41032; K41051; K41052; K41053; K41054; K41059; L41069; A51079; B41004; B41009; A30072; A30073; A30074; A30075; D20039; D20040; E30119; H30154; 010012; A20020; A20034; K41055; K41056; K41058; L30156; L30157; L30159; L30160; L30161; L41067; L41070; L41074; A30068; B51091; B51093; B51094; B51095; C30088; C30089; C30090; C30091; D10005; E41021; E41027; E41028; E41030; L30163; L30167; B51098; C51112; B20032; D51126; D51130; D51133; D51134; L30164; L30166; F30121; F30123; A20015; A20016; A20022; B10001; B20029; B20031; B20033; B30079; B30080; B41001; B41003; B41006; B41007; B41008; B41010; C51102; C51107; C51109; C51110; F30124; F30125; F30126; G30141; H20046; H20049; H20050; H20053; H20054; I10008; I10013; J20058; J20062; L30158; L40161; A20021; L41072.  Serial Numbers starting with AF0: 1040-L5; 1045-A6; 1043-L5; 1029-K5; 1037-L5; 1005-I5; 1032-K5; 1036-L5; 1035-L5; 1034-L5; 1033-L5; 1032-L5; 1031-K5; 1030-K5; 1028-K5; 1027-K5; 1026-K5; 1025-K5; 1024-K5; 1023-K5; 1022-K5; 1021-K5; 1020-K5; 1019-K5; 1018-K5; 1017-K5; 1016-K5; 1015-K5; 1014-J5; 1013-J5; 1012-J5; 1011-J5; 1009-I5; 1008-I5; 1007-I5; 1004-I5; 1003-I5; 1001-I5; 1055-A6; 1051-A6; 1048-A6; 1046-A6; 1042-L5; 1010-I5; 1044-A6; 1041-L5; 1038-L5; 1006-I5; 1053-A6; 1052-A6; 1049-A6; 1047-A6; 1039-L5.
  • Product Classification
    Anesthesiology Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    The units have been distributed to distributors and end-users such as hospitals and clinics nationwide. There are 3 foreign accounts in Australia, El Salvador, and Venezuela.
  • Product Description
    Anestar and Anestar Plus Anesthesia System.
  • Manufacturer
    Datascope Corp

Manufacturer

Datascope Corp
  • Manufacturer Address
    Datascope Corp, 800 MacArthur Blvd, Mahwah NJ 07430-2001
  • Source
    USFDA