FDA recall Z-2108-2021

Mindray DS USA, Inc. dba Mindray North America · Class III · device

Product

3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-060044-00) and TM80 Telepack (Model Number 115-047565-00 / 120-018867-00). Used with physiological data monitor.

Reason for recall

Telepack may not power on when using the 3AA battery cradle.

Distribution

Distributed US nationwide and Canada.

Key facts

Status: Terminated
Initiation date: 2021-05-27
Report date: 2021-07-28
Termination date: 2022-08-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Mahwah, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2108-2021