BEUDAMED
    FDA Enforcement Class I Ongoing

    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System

    Recall: Z-1274-2023 · Reported April 12, 2023

    Enforcement

    Recall Number
    Z-1274-2023
    Event ID
    91756
    Classification
    Class I
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Abbott Diabetes Care, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 12, 2023
    Initiation Date
    February 13, 2023
    Classification Date
    April 6, 2023
    Address
    1360 S Loop Rd, Alameda, CA, 94502-7000, United States

    Description

    FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System

    Reason

    Lithium-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.

    Code Info

    REF/UDI-DI/Lot: 71936-01/357599000981/01C083D, 02C054D, 03C033D, 03B356D, 01B320D, 03B266D, 02B250D, 02B181D, 01B161D, 01B096D, 05B081D, 03B035D, 02A314D, 02A238D, 02A191D, 01A160D, 03A132D, 01A093D, 02A085D, 01A074D, 02A064D, 02A063D, 02A016D, 04Z351D, 01Z318D, 01Z282D, 01Z246D, 04Z191D, 03Z178D, 03Z151D, 03Z128D, 05Z115D, 03Z057D; 71937-01/357599000974/02B099D, 01B082D, 02A098D, 03A097D, 02A094D, 02A092D, 03A093D, 04A091D, 01A091D, 02A056D, 01A055D, 05A050D, 01A049D, 01Z360D, 01Z352D, 01Z346D, 02Z346D, 01Z344D, 02Z339D, 01Z338D, 03Z337D, 03Z336D, 03Z318D, 01Z311D, 03Z309D, 01Z305D, 05Z304D, 03Z303D, 02Z290D, 03Z290D, 02Z289D, 03Z246D, 01Z238D, 02Z178D, 03Z177D, 02Z177D, 03Z172D, 05Z172D, 02Z163D, 02Z151D, 03Z116D, 01Z116D, 01Z102D, 04Z083D, 02Z057D, 01Z056D, 02Z036D, 01Z024D, 01Y861D, 02Y854D, 03Y845D, 02Y845D, 01Y845D, 03Y839D, 01Y838D, 06Y830D, 03Y820D, 01Y820D, 02Y811D, 03Y811D, 01Y811D, 06Y795D, 05Y795D, 02Y791D, 03Y790D, 02Y789D, 01Y782D, 02Y782D, 01Y781D, 01Y776D, 01Y763D, 02Y762D, 02Y763D; 71938-01/357599002008/04C216D, 02C189D, 04C160D, 01C116D, 04C059D, 01C045D, 01C040D, 01C041D, 01C038D, 02C040D, 01C037D, 02C028D, 02C025D, 02C020D, 02C021D, 02C014D, 03C007D, 02B344D, 03B348D, 01B347D, 01B344D, 03B341D, 01B324D, 01B322D, 03B321D, 02B317D, 02B308D, 04B308D, 01B307D, 03B289D, 01B287D, 01B286D, 02B280D, 01B265D, 01B256D, 02B254D, 01B252D, 02B252D, 02B242D, 03B237D, 01B235D, 01B218D, 01B216D, 04B211D, 01B209D, 02B202D, 01B202D, 03B194D, 01B194D, 02B190D, 03B190D, 01B189D, 01B190D, 02B189D, 05B187D, 02B187D, 01B166D, 01B167D, 02B167D, 01B165D, 01B162D, 03B160D, 01B159D, 03B158D, 01B152D, 02B152D, 02B148D, 01B148D, 01B146D, 02B146D, 01B145D, 04B134D, 01B134D, 01B130D, 03B127D, 07B120D, 02B106D, 02B105D, 03B105D, 05B099D, 03B090D, 04B090D, 01B081D, 04B076D, 02B070D, 02B074D, 02B068D, 02B067D, 02B065D, 01B063D, 02B062D, 03B062D, 04B040D, 01B040D, 01B034D, 01B035D, 03B034D, 02B027D, 02B026D, 01B015D, 04B015D, 01B013D, 03B012D, 04B012D, 01B012D, 03B009D, 01A366D, 01A351D, 01A347D, 02A339D, 01A338D, 01A337D, 01A329D, 01A324D, 02A324D, 02A317D, 03A317D, 04A302D, 01A279D, 03A279D, 06A277D, 01A262D, 02A261D, 01A248D, 01A247D, 03A244D, 04A244D, 01A240D, 04A238D, 01A238D, 04A232D, 01A232D, 03A224D, 04A197D, 04A196D, 01A196D, 01A197D, 03A191D, 01A188D, 01A178D, 01A181D, 02A181D, 03A181D, 02A176D, 05A176D, 01A175D, 02A175D, 03A176D, 04A176D, 05A168D, 02A164D, 02A141D, 02A142D, 04A140D, 04A142D, 02A140D, 01A137D, 01A136D, 02A136D, 01A135D, 01A134D, 01A132D, 02A133D, 01A133D, 06A132D, 01A125D, 02A125D, 04A122D, 03A122D, 01A121D, 02A120D, 01A120D, 02A118D, 02A119D, 01A116D, 02A115D, 01A104D, 01A100D, 04A099D, 02A099D, 01A094D, 01A097D, 02A097D, 01A092D, 03A092D, 04A090D, 05A090D, 03A079D, 04A079D, 03A077D, 04A077D, 01A076D, 03A072D, 04A064D, 01A064D, 05A059D, 01A059D, 04A058D, 05A058D, 01A057D, 02A057D, 03A056D, 03A050D, 03A036D, 01A034D, 02A034D, 02A029D, 01A030D, 02A030D, 01A028D, 01A029D, 02A028D, 03A030D, 01A015D, 01A013D, 01A014D, 03A010D, 02A008D, 01A009D, 01A008D, 02A007D, 01A003D, 07Z351D, 01Z345D, 03Z345D, 01Z339D, 02Z338D, 02Z331D, 01Z331D, 03Z330D, 04Z330D, 05Z330D, 04Z326D, 02Z326D, 02Z325D, 01Z326D, 01Z325D, 03Z319D, 05Z319D, 04Z319D, 02Z303D, 03Z281D, 02Z275D, 01Z266D, 01Z262D, 02Z261D, 03Z261D, 02Z259D, 01Z252D, 01Z241D, 03Z241D, 04Z228D, 02Z227D, 02Z226D, 01Z224D, 02Z221D, 02Z220D, 01Z217D, 04Z199D, 04Z197D, 01Z197D, 02Z191D, 02Z189D, 01Z184D, 02Z179D, 04Z179D, 01Z175D, 01Z170D, 02Z171D, 04Z165D, 05Z165D, 01Z165D, 04Z158D, 02Z155D, 01Z150D, 01Z142D, 03Z141D, 01Z138D, 04Z137D, 01Z136D, 01Z135D, 01Z133D, 01Z128D, 01Z126D, 02Z121D, 01Z112D, 03Z109D, 01Z109D, 01Z108D, 02Z107D, 02Z099D, 01Z098D, 03Z095D, 03Z094D, 01Z094D, 02Z092D, 02Z093D, 01Z087D, 03Z086D, 04Z086D, 02Z085D, 01Z083D, 03Z083D, 02Z082D, 03Z081D, 01Z081D, 02Z080D, 01Z078D, 02Z073D, 03Z072D, 03Z073D, 03Z070D, 02Z067D, 04Z066D, 05Z066D, 02Z060D, 03Z060D, 02Z059D, 01Z058D, 04Z057D, 03Z053D, 01Z050D, 02Z050D, 04Z045D, 01Z044D, 01Z045D, 02Z045D, 01Z043D, 02Z044D, 01Z042D, 02Z039D, 03Z039D, 01Z039D, 01Z038D, 02Z037D, 01Z035D, 01Z031D, 02Z030D, 01Z030D, 03Z029D, 01Z025D, 02Z025D, 04Z024D, 02Z024D, 03Z024D, 01Z023D, 02Z022D, 03Z022D, 02Z018D, 01Z021D, 02Z016D, 03Z017D, 01Z016D, 03Z015D, 01Z008D, 01Z009D, 02Z008D, 02Z007D, 02Z002D, 03Z002D, 01Z002D, 01Y865D, 02Y865D, 03Y862D, 02Y860D, 01Y860D, 02Y855D, 05Y854D, 01Y854D, 01Y855D, 04Y854D, 04Y851D, 05Y851D, 02Y848D, 01Y847D, 01Y834D, 03Y834D, 02Y833D, 01Y833D, 05Y832D, 02Y831D, 01Y831D, 03Y819D, 04Y819D, 02Y810D, 03Y809D, 04Y809D, 01Y803D, 02Y803D, 03Y802D, 04Y802D, 01Y788D, 02Y788D, 01Y785D, 01Y777D, 02Y776D, 01Y775D, 01Y774D, 01Y761D, 02Y761D, 03Y760D

    Distribution

    U.S. Nationwide.

    Quantity

    1,373,311