FDAFDA · Food and drugs·Recall number Z-1596-2014
SPHERES 8801075 5/TRAY 12PK
Published November 26, 2014 · Recall initiated: April 24, 2014
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
Medtronic Navigation is recalling certain Medtronic single-use, disposable devices because there was not sufficient control to assure that returned, unused devices were appropriately examined for product and/or package damage to ensure sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Medtronic Navigation, Inc.
- Distributor
- Nationwide Distribution
- Lot
- Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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