Recall Z-1315-2016— Scottcare Corporation
Class II · Terminated
Class II FDA medical device recall by Scottcare Corporation, initiated 2016-02-25, terminated 2019-02-15. It names one FDA 510(k) clearance: K092947. Product: 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.. Reason: The firm received a complaint of the battery exploding while recharging..
- Recalling firm
- Scottcare Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-02-25
- Terminated
- 2019-02-15
- Firm location
- Cleveland, OH, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The firm received a complaint of the battery exploding while recharging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.