FDAClass IINovember 26, 2014

Patient Tracker 9733534xom ENT 1pk recall: Sterility Concern

PATIENT TRACKER 9733534XOM ENT 1PK

Why was Patient Tracker 9733534xom ENT 1pk 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.: 131212C 130827E 130827E 131113B 131203C 131113D 131018A 130212B 131105B 130429E 130815D 130815D 130815C 130409G 130409G 130510E 130422A 130410A 130510E 130409G

Product
PATIENT TRACKER 9733534XOM ENT 1PK
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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