Reported Jul 5, 2017 · Terminated
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing,…
Mindray DS USA, Inc. dba Mindray North America
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mindray DS USA, Inc. dba Mindray North America · 800 Macarthur Blvd · Mahwah, NJ · 07430-2001
Is this the product you have?
- TI Transport Monitor/Module
- Battery Pack Product Usageintended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters
- Lot codes and dates
- two sales brochuresp/n: 0002-08-30034
- and 0002-08-30035 two copies of labels
047-014270-00047-010964-00047-018754-00
- two copies of operator's manuals115-040812-00 and TNC 14-FZ007-F-001
- Amount recalled
- 2718 batteries
Where it was sold
- Nationwide
Why it was recalled
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
This product could cause temporary or reversible health problems — stop using it.
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