Upgrd Prgm 9734638 ADD Axiem Navigation recall: Sterility Concern
UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
Why was Upgrd Prgm 9734638 ADD Axiem Navigation 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.: 6148186
- Product
- UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
- 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)