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Abbott Diabetes Care, Inc. Recall 91756

Description: FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System

Abbott Diabetes Care, Inc. Recall 91756 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-1275-2023
Event ID91756
Event DescriptionFreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Product TypeDevices
DistributionU.S. Nationwide.
Recall ReasonLithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with readers. Do not use reader if it is damaged, cracked, swelling, too hot to hold, it will no longer hold charge, or it fails Reader Test. Do not use other chargers. User Manual update includes instructions on reader safe storage, charging, use.
Device Classification20230412
Device Code InfoREF/UDI-DI/Lot: 71951-01/357599805005/02C313D, 01C256D, 03C222D ,01C174D ,03C166D, 03C152D, 01C143D, 02C115D, 01C084D, 02C087D, 01C073D, 03B251D, 04B251D, 02B251D, 02B109D, 02B082D, 03B082D, 03B014D, 04A350D, 02A289D, 02A279D; 71952-01/357599804008/01B179D, 02B176D, 02B174D, 03B174D, 02B172D, 03B172D, 01B172D, 02B163D, 01B163D, 02B159D, 02B160D, 01B160D, 04B154D, 05B154D, 02B154D, 04B152D, 03B152D, 01B147D, 02B147D, 03B144D, 01B131D, 01B133D, 02B132D, 01B132D, 03B131D, 02B131D, 01B125D, 02B124D, 05B124D, 05B120D, 01B118D, 02B118D, 01B116D, 02B116D, 03B116D, 04B112D, 02B112D, 04B111D, 01B111D, 02B111D, 01B110D, 01B103D, 02B103D, 01B100D, 01B098D, 03B097D, 03B096D, 02B096D, 04B095D, 02B095D, 03B095D, 01B086D, 01B088D, 02B088D, 01B085D, 02B085D, 03B085D, 02B084D, 01B076D, 04B070D, 02B069D, 02B064D, 03B064D, 01B064D, 01B053D, 02B053D, 02B050D, 03B041D, 02B037D, 03B037D, 04B037D, 05B034D, 01B033D, 02B033D, 03B032D, 06B021D, 01B018D, 01B014D, 02B004D, 01A346D, 05A344D, 01A343D, 04A340D, 03A340D, 02A338D, 01A330D, 02A329D, 02A322D, 01A322D, 02A321D, 01A316D, 03A316D, 02A315D, 03A311D, 02A311D, 03A310D, 01A311D, 01A308D, 01A302D, 01A301D, 01A296D, 02A296D, 01A289D, 03A288D, 03A275D, 02A275D, 01A272D, 01A273D, 02A272D, 03A269D, 03A263D, 01A258D, 01A256D, 02A256D, 02A255D, 01A255D, 01A253D, 01A254D, 01A252D, 03A233D, 03A225D, 01A223D, 01A224D, 02A220D, 03A220D, 01A220D, 01A210D, 02A210D, 02A209D, 01A206D, 02A206D, 03A206D, 04A205D; 71953-01/357599803001/06B074F, 01C346D, 03C340D, 01C341D, 02C340D, 01C340D, 02C334D, 04C334D, 01C334D, 01C327D, 01C332D, 01C326D, 01C325D, 02C325D, 01C322D, 02C321D, 03C320D, 01C318D, 01C317D, 01C313D, 02C312D, 01C307D, 01C308D, 03C305D, 01C305D, 02C305D, 01C300D, 02C298D, 01C299D, 01C298D, 03C294D, 06C292D, 02C294D, 04C292D, 02C287D, 01C283D, 03C279D, 02C278D, 01C273D, 04C276D, 01C272D, 01C276D, 08C271D, 01C266D, 03C270D, 02C265D, 02C262D, 02C257D, 03C257D, 01C257D, 02C256D, 03C256D, 02C255D, 03C251D, 02C250D, 01C249D, 02C245D, 01C245D, 04C243D, 02C242D, 02C243D, 01C242D, 01C243D, 03C242D, 04C241D, 02C237D, 03C238D, 01C237D, 03C236D, 02C236D, 01C228D, 02C229D, 03C224D, 01C227D, 01C224D, 02C224D, 01C223D, 02C223D, 03C213D, 01C207D, 01C209D, 02C208D, 03C207D, 01C201D, 02C199D, 05C199D, 03C199D, 03C196D, 02C193D, 01C194D, 01C188D, 02C188D, 01C186D, 01C182D, 01C181D, 02C181D, 02C172D, 05C165D, 03C165D, 01C161D, 01C159D, 03C159D, 01C146D, 05C146D, 01C144D, 02C145D, 02C143D, 01C140D, 02C140D, 03C140D, 04C140D, 04C138D, 01C137D, 01C138D, 01C133D, 01C136D, 02C136D, 03C133D, 02C133D, 02C130D, 03C129D, 03C126D, 03C123D, 03C117D, 02C116D, 02C112D, 01C109D, 02C080D, 01C075D, 01C077D, 02C074D, 03C075D, 02C073D, 03C074D, 01C074D, 01C034F, 02C032F, 01C028F, 02C031F, 03C031F, 03C028F, 02C025F, 02C013D, 01C014D, 03C013D, 01C011D, 01C012D, 02C010D, 02C005D, 01C006D, 03C005D, 02B363D, 01B362D, 02B362D, 01B356D, 04B356D, 05B356D, 02B356D, 04B354D, 03B351D, 04B352D, 06B349F, 02B344F, 01B343F, 04B302F, 01B342F, 02B342F, 02B343F, 01B341F, 02B341F, 01B341D, 02B341D, 01B302F, 01B340F, 02B340F, 03B302F, 04B301F, 01B337D, 01B337F, 02B337F, 01B336F, 02B336F, 01B335F, 03B335F, 02B333D, 01B334D, 01B333D, 01B308D, 02B328F, 01B327F, 03B326F, 04B326F, 01B323F, 01B326F, 06B322F, 01B305D, 07B322F, 05B322F, 01B313D, 03B312D, 03B313D, 02B312D, 01B310D, 01B308F, 01B309F, 01B309D, 02B308F, 03B306F, 01B306F, 02B306F, 01B306D, 02B305D, 01B289D, 02B289D, 01B288D, 02B229D, 02B216D, 01B215D, 02B211D, 02B208D, 01B208D, 01B205D, 01B207D, 03B203D, 02B203D, 03B109D, 05B082D, 02B083D, 02B082F, 04B082F, 02B081F, 03B081F, 02B078F, 05B078F, 01B077F, 05B076F, 02B076F, 05B075F, 04B074F, 05B071F, 01B071F, 02B046F, 05B043F, 06B046F, 09B046F, 02B042F, 03B043F, 05B046F, 03B041F, 05B041F, 03B036F, 01B036F, 01B039F, 03B039F, 02B036F, 05B035F, 02B035F, 04B034F, 04B035F, 06B034F, 07B034F, 02B034F, 11B021F, 02B013F, 04B013F, 01B015F, 01B012F, 01B014F, 05B013F, 03B012F, 01B008F, 01B011F, 01B007F, 02B007F, 01A364D, 02A363D, 02A358D, 01A352D, 03A352D, 02A351D, 03A350D, 03A344D, 02A340D, 01A328D, 03A325D, 04A325D, 02A304D, 02A303D, 02A297D, 02A298D, 03A296D, 01A290D, 02A283D, 01A283D, 01A281D, 02A280D, 03A268D, 01A267D, 02A268D, 03A266D, 04A262D, 01A259D, 01A260D, 02A248D, 02A240D, 06A232D, 02A232D, 01A231D, 03A231D, 04A225D, 05A225D, 01A219D, 04A218D, 05A218D, 06A218D, 02A212D, 01A211D, 02A211D, 03A210D, 02A205D, 03A205D, 01A204D, 02A203D, 04A202D, 01A202D, 04A198D, 05A198D, 01A198D, 02A198D, 03A198D
Center Classification Date20230406
Recall Initiation Date20230213
Recalling FirmAbbott Diabetes Care, Inc.
Initial Notification Letter
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