Spheres 8801075 5/tray 12pk recall: Sterility Concern
SPHERES 8801075 5/TRAY 12PK
Why was Spheres 8801075 5/tray 12pk recalled?
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 should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot No.: 1207251 1301091 1301081 1211141 1301151 1302051 1303141 1303121 1303191 1304031 1304081 1303071 1305221 1305281 1306181 1306231 1307041 1307051 1307111 1307131 1307121
- Product
- SPHERES 8801075 5/TRAY 12PK
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 26,674 total
- Distribution
- Nationwide Distribution
- Recall date
- November 26, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)