Device product
FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
Z-1273-2023
Product summary
- Event
- Event 91756
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 336,085
- Official record key
device-enforcement:Z-1273-2023
Official wording
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 information: REF/UDI-DI/Lot: 71525-01/357599000219/02Y702D, 01Y699D, 02Y699D, 01Y698D, 02Y697D, 04Y690D, 03Y690D, 01Y683D, 02Y683D, 01Y674D, 02Y672D, 01Y669D, 02Y666D, 01Y659D, 02Y658D, 02Y656D, 04Y655D, 01Y655D, 01Y652D, 02Y653D, 03Y653D, 03Y651D, 01Y641D, 02Y638D, 01Y637D, 02Y635D, 01Y629D, 03Y628D, 01Y628D, 02Y628D, 02Y621D, 02Y622D, 02Y620D, 02Y608D, 04Y608D, 01Y608D, 01Y603D, 03Y599D, 04Y600D, 02Y596D, 06Y596D, 03Y596D, 07Y547D, 07Y546D, 08Y546D, 05Y540D, 06Y538D, 05Y537D, 03Y536D, 04Y523D, 02Y522D, 02Y519D, 02Y512D, 01Y512D, 01Y511D, 02Y510D, 01Y505D, 02Y504D, 04Y355D, 02Y355D, 01Y352D, 01Y349D, 03Y348D, 01Y348D, 02Y348D, 01Y339D, 01Y335D, 02Y334D, 02Y335D, 03Y314D, 01Y313D, 02Y312D, 01Y312D, 02Y311D, 01Y311D, 02Y310D, 04Y310D, 02Y307D, 03Y307D, 01Y304D, 02Y303D, 02Y304D; 71701-01/357599000226/01Y702D, 01Y694D, 03Y693D, 02Y686D, 03Y683D, 02Y574D, 01Y563D, 02Y563D, 01Y564D, 03Y562D, 01Y552D, 02Y552D, 06Y550D, 05Y539D, 05Y538D, 06Y537D, 01Y536D, 01Y532D, 02Y531D, 03Y522D, 02Y518D, 02Y511D, 01Y508D, 02Y505D, 04Y356D, 01Y356D, 02Y356D, 01Y321D, 01Y320D, 02Y320D, 01Y317D, 02Y317D; 71739-01/357599000240/03Y754D, 03Y734D, 01Y705D, 01Y671D
Distribution pattern: U.S. Nationwide.
Derived failure modes
-
Unknown
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.