Class 3 Device Recall Benevision Telepack battery cradle

• Date Initiated by Firm: May 27, 2021
• Create Date: July 21, 2021
• Recall Status: Terminated on August 11, 2022
• Recall Number: Z-2108-2021
• Recall Event ID: 88209
• 510(K)Number: K193391
• Product Classification: System, network and communication, physiological monitors - Product Code MSX
• 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.
• Code Information: Part Number 045-001699-01; Awaiting additional details
• Recalling Firm/ Manufacturer: Mindray DS USA, Inc. dba Mindray North America; 800 Macarthur Blvd; Mahwah NJ 07430-2001
• For Additional Information Contact: Diane Arpino; 201-995-8407
• Manufacturer Reason for Recall: Telepack may not power on when using the 3AA battery cradle.
• FDA Determined 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 in Commerce: 804
• Distribution: Distributed US nationwide and Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MSX and Original Applicant = Shenzhen Mindray Bio-medical Electronics Co., LTD.