3AA battery cradle — Class III medical device recall Z-2108-2021
Terminated recall by Mindray DS USA, Inc. dba Mindray North America, reported 2021-07-28, distributed nationwide. Telepack may not power on when using the 3AA battery cradle.
| Recall number | Z-2108-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Mindray DS USA, Inc. dba Mindray North America, Mahwah, NJ, United States |
| Recall initiated | 2021-05-27 |
| Classified | 2021-07-21 |
| Reported by FDA | 2021-07-28 |
| Terminated | 2022-08-11 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 804 |
| Model numbers | 045-001699-01, 115-047565-00, 115-047566-00, 115-060044-00, 120-018867-00 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2108-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.