Medical device recalls Moderate risk

Scottcare Corporation recalls TeleSentry Battery, 3.7 Li-Ion Polymer Battery, CAUTION Do not expose to high temperature. Do not disassemble. Dispose…

Recall date
February 25, 2016
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-1315-2016
FDA classification
Class II
Brand / firm
Scottcare Corporation
Sold / distributed
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.

Why it was recalled

The firm received a complaint of the battery exploding while recharging.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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