FDAFDA · Food and drugs·Recall number Z-1595-2014
SPHERES 8801071 1/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.: 1203122 1205291 1206251 1306081 1309101
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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