FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Reported: April 12, 2023 Initiated: February 13, 2023 #Z-1275-2023
Product Description
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System
Reason for Recall
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.
Details
- Recalling Firm
- Abbott Diabetes Care, Inc.
- Units Affected
- 1,534,532
- Distribution
- U.S. Nationwide.
- Location
- Alameda, CA
Frequently Asked Questions
What product was recalled? ▼
FreeStyle Libre Reader, REF: 71951-01, 71952-01, 71953-01 a component of the FreeStyle Libre 2 Flash Glucose Monitoring System. Recalled by Abbott Diabetes Care, Inc.. Units affected: 1,534,532.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 12, 2023. Severity: Critical. Recall number: Z-1275-2023.
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