FDAFDA · Food and drugs·Recall number Z-2634-2017
TI Transport Monitor/Module Battery Pack Product Usage: intended for monitoring, displaying, reviewing, storing, alarming and transferring of multiple physiological parameters.
Published July 5, 2017 · Recall initiated: April 28, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Mindray has received two reports from outside the United States that the battery pack for TI transport monitor/module overheated.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mindray DS USA, Inc. dba Mindray North America
- Distributor
- US Nationwide Distribution
- Lot
- two sales brochures: p/n: 0002-08-30034 and 0002-08-30035 two copies of labels: 047-014270-00, 047-010964-00, 047-018754-00 two copies of operator's manuals: 115-040812-00 and TNC 14-FZ007-F-001
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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