FDA Medical Device Recalls (openFDA)
Mindray DS USA, Inc. dba Mindray North America: 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.
- Recall number
- Z-2108-2021
- Recalling firm
- Mindray DS USA, Inc. dba Mindray North America
- 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.
- Status
- Terminated
- Initiated
- 2021-05-27
- Posted
- not on file
- Terminated
- 2022-08-11
- Reason
- Telepack may not power on when using the 3AA battery cradle.
- Root cause
- Process control
- Action
- Urgent Medical Device Correction notification letters dated 5/27/21 were sent to customers. Actions to be taken by the Customer/User Please discard all 3AA battery cradles in stock that were purchased between October 1, 2020 and March 31, 2021. Shipping records indicate your facility has XX cradles affected by this recall. Continue to use the TD60 and TM80 telepacks normally with either the 2AA battery cradle (TD60 only), or rechargeable Li-ion battery pack, if previously purchased. Please complete and return the Acknowledgement and Receipt form (found on the 3rd page of this recall notice) by June 30, 2021. Product and Distribution Information The 3AA cradles included with the TD60 or TM80 telepacks distributed between October 1, 2020 and March 31, 2021 may be affected by this recall. Other Information Please complete the attached Acknowledgement and Receipt Form and return in the stamped envelope provided. Contact information is provided below should you have questions. Adverse reactions or quality problems experienced with the use of this product may be reported to FDAs MedWatch Adverse Event Reporting program either online, by regular mail or by fax. We apologize for any inconvenience this may cause and appreciate your cooperation. Sincerely, Diane Arpino Director, Quality Operations and Regulatory Affairs Mindray DS USA, Inc. d.arpino@mindray.com 201.995.8407 Distributors were instructed to do the following: Actions to be taken by the Customer/User Please discard all 3AA battery cradles in stock that were purchased between October 1, 2020 and March 31, 2021. Shipping records indicate your facility purchased 6 cradles affected by this recall. Continue to use the TM80 telepack normally with rechargeable Li-ion battery pack, if previously purchased. Please contact each customer which you have distributed the affected 3AA battery cradles. The format for the recall notification to send to your customers is provided. We recommend that you send the notificati
- Quantity
- 804
- Distribution
- Distributed US nationwide and Canada.
- Lot, serial or model codes
- Part Number 045-001699-01; Awaiting additional details
- 510(k) numbers
- ["K193391"]
- PMA numbers
- not on file
- Product code
- MSX
- Firm FEI
- 2221819
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28