Home › Device types › PZE
Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
FDA product code PZE · Class 3 · Unknown
13
Registered devices
117,148
Adverse events
3
Recalls
0
510(k) clearances
Devices with this code
FreeStyle Libre 14 day — ABBOTT DIABETES CARE INCFreeStyle Libre 14 day — ABBOTT DIABETES CARE INCFreeStyle Libre 14 day — ABBOTT DIABETES CARE INCFreeStyle Libre 14 day — ABBOTT DIABETES CARE INCFreeStyle Libre — ABBOTT DIABETES CARE INCFreeStyle LibreLink — ABBOTT DIABETES CARE INCFreeStyle LibreLink — ABBOTT DIABETES CARE INCFreeStyle Libre — ABBOTT DIABETES CARE INCFreeStyle Libre — ABBOTT DIABETES CARE INCFreeStyle Libre 14 day — ABBOTT DIABETES CARE INCFreeStyle Libre — ABBOTT DIABETES CARE INCFreeStyle Libre — ABBOTT DIABETES CARE INCFreeStyle Libre — ABBOTT DIABETES CARE INC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-02-13 | Abbott Diabetes Care, Inc. | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with rea |
| 2023-02-13 | Abbott Diabetes Care, Inc. | Lithium-ion batteries in glucose monitoring system readers may swell, overheat, or pose fire hazard. Only use the charging cable/power adapter included with rea |
| 2021-03-16 | Cardinal Health Inc. | Due to shipping delays the devices were exposed to temperature excursions of 31.9F, intermittently over a 2 hour and 15 minute period of time which may cause in |
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