3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepack (Model Number 115-047566-00 /115-06004
Summary
The FDA issued a Class III for 3AA battery cradle (Part Number 045-001699-01) used with BeneVision TD60 Telepac by Mindray DS USA, Inc. dba Mindray North America. Reason: Telepack may not power on when using the 3AA battery cradle..
Details
Source
Device Recall
External ID
Z-2108-2021
Action Date
2021-07-28
Status
Terminated
Category
device
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.
Lot/Code Info: Part Number 045-001699-01; Awaiting additional details
Quantity Affected: 804
Reason for Recall
Telepack may not power on when using the 3AA battery cradle.
Distribution
Distributed US nationwide and Canada.
Type: Voluntary: Firm initiated
Recall Initiated: 2021-05-27
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 191 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Mindray DS USA, Inc. dba Mindray North America has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Mindray DS USA, Inc. dba Mindray North America) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Mindray DS USA, Inc. dba Mindray North America have FDA actions?
Mindray DS USA, Inc. dba Mindray North America has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-2108-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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