FDA-Device2016-04-13Class II
TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.
Scottcare Corporation
Hazard
The firm received a complaint of the battery exploding while recharging.
Sold states
Worldwide Distribution -- USA, including the states of CA, CT, DE, FL, IL, KS, KY, MA, MD, MI, MN, MO, NC, NH, NJ, NM, NV, NY, OH, PA, SC, TN, TX, & WV; and, the country of Canada.
Affected count
9,067 batteries
Manufactured in
4791 W 150th St, N/A, Cleveland, OH, United States
Products
TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose of properly. Use specified charger only. 60pC/140pF The ScottCare Corporation. Intended for diagnostic evaluation of patients who experience transient symptoms or asymptomatic events that may suggest cardiac arrhythmia.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1315-2016Don't want to check this manually?
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