FDAClass IIJune 26, 2019

Monarch Medical Technologies EndoTool IV recall

Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.

Why was Monarch Medical Technologies EndoTool IV recalled?

Insulin dosing calculations were erroneously high.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA 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?

Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10

Product
Monarch Medical Technologies EndoTool IV, Versions 1.8, Version 1.8.5 and higher, and Version 1.9 and Version 1.10.
Recalling firm
Monarch Medical Technologies
Quantity
83 downloads
Distribution
Nationwide and Dubai
Recall date
June 26, 2019
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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