FreeStyle Libre Readers recalled due to lithium-ion battery fire hazard
FreeStyle Libre Reader batteries may swell, overheat, or create fire hazard. Do not use if the device is damaged, cracked, swollen, excessively hot, won't hold charge, or fails Reader Test.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this as Class I, which mandates a minimum severity score of 4. The hazard involves potential fire or thermal damage from lithium-ion battery defects in a widely distributed medical device. No illnesses or injuries have been reported to date.
Plain-English summary
Abbott Diabetes Care, Inc. is recalling FreeStyle Libre Readers (models REF 71525-01, 71701-01, and 71739-01), which are components of the FreeStyle Libre Flash Glucose Monitoring System. Approximately 336,085 units were distributed nationwide.
The lithium-ion batteries in these readers may swell, overheat, or pose a fire hazard. Only the charging cable and power adapter included with the reader should be used; other chargers are unsafe.
Patients using affected devices should discontinue use immediately if the reader is damaged, cracked, swelling, too hot to hold, will no longer hold a charge, or fails the Reader Test. Consult the updated User Manual for instructions on safe storage and proper charging.
The recalled product
- Product
- FreeStyle Libre Reader, REF: 71525-01, 71701-01, 71739-01 a component of the FreeStyle Libre Flash Glucose Monitoring System
- Manufacturer
- Abbott Diabetes Care, Inc.
- Hazard
- fire
- battery-swell
- thermal-hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
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