Shunt KIT 9733605 Non-invasive recall: Sterility Concern
SHUNT KIT 9733605 NON-INVASIVE
Why was Shunt KIT 9733605 Non-invasive 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.: 120628B 130204E 130314H 121113H 130508B 130612A 130709 130325 130710 130729A 130826 130923B 131016C 131025F 130923B 131127A
- Product
- SHUNT KIT 9733605 NON-INVASIVE
- 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)