FDAClass IINovember 26, 2014

Spheres 8801071 1/tray 12pk recall: Sterility Concern

SPHERES 8801071 1/TRAY 12PK

Why was Spheres 8801071 1/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.: 1203122 1205291 1206251 1306081 1309101

Product
SPHERES 8801071 1/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)
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