FDA recall Z-1976-2019
Cardiocommand Inc. · Class III · device
Product
TAPSYSTEM Model 2A, REF 8002A
Reason for recall
There is a potential for an assembly error resulting in the battery wire being connected to the ON/OFF power switch incorrectly.
Distribution
United States - AR, NM, PA, TX, and WA.
Key facts
- Status
- Terminated
- Initiation date
- 2019-06-24
- Report date
- 2019-07-24
- Termination date
- 2021-04-01
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Tampa, FL, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1976-2019