Z-2108-2021 Class III Terminated
FDA device recall Z-2108-2021 was initiated by Mindray DS USA, Inc. dba Mindray North America on May 27, 2021 and is designated Class III. Reason for recall: Telepack may not power on when using the 3AA battery cradle. The recall status is terminated (terminated August 11, 2022). Affected quantity: 804.
Recall Details
- Product Type
- Devices
- Report Date
- July 28, 2021
- Initiation Date
- May 27, 2021
- Termination Date
- August 11, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 804
Product Description
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 Pattern
Distributed US nationwide and Canada.
Code Information
Part Number 045-001699-01; Awaiting additional details