Medtronic Instrument Set EM ENT recall
Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved…
Why was Medtronic Instrument Set EM ENT recalled?
The instruments are not able to pass instrument verification which is performed prior to the use of each instrument.
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?
Each of the devices within the kit are labeled with information specific to each of the reusable devices within the kit and those devices are what goes into the customer inventory. The outer box where the lot number is printed is discarded by the customer on receipt and the separate devices within the box are what is stored on the shelf. Therefore, no kit lot number is being provided.
- Product
- Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, RX. This kit contains 9733449, Straight Suction, 9733450, 70 deg Curved…
- Recalling firm
- Medtronic Navigation, Inc.
- Quantity
- 13 kits
- Distribution
- Worldwide Distribution - US (nationwide) and Internationally to Canada.
- Recall date
- August 30, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)