Anestar and Anestar Plus Anesthesia System.
This recall has been terminated (originally issued June 2, 2006).
- Company
- Datascope Corp.
- Recall Initiated
- March 17, 2006
- Posted
- June 2, 2006
- Terminated
- August 1, 2006
- Recall Number
- Z-0929-06
- Quantity
- 337 UNITS
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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.
Lot / Code Info
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.
Root Cause
Other
Action Taken
Field correction communications were sent 3/17/2006 to all accounts via certified mail, return receipt requested, signature required.