FreeStyle Libre Reader recall
FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
Why was FreeStyle Libre Reader recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- FreeStyle Libre Reader, REF: 71936-01, 71937-01, 71938-01 a component of the FreeStyle Libre 14 Day Flash Glucose Monitoring System
- Recalling firm
- Abbott Diabetes Care, Inc.
- Quantity
- 1,373,311
- Distribution
- U.S. Nationwide.
- Recall date
- April 12, 2023
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)