FDAClass IIOctober 28, 2015

Ambitex NMD400 Nitrile Exam Gloves recall

Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a…

Why was Ambitex NMD400 Nitrile Exam Gloves recalled?

Ambitex Nitrile NMD400 Exam Gloves size medium on exam hold were inadvertently placed into commerce. The product was under Exam Hold because samples pulled from a shipment manufactured by the firm failed the water leak test performed by FDA as described at 21 CFR 800.20.

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?

Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314

Product
Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the hand for medical purposes to provide a…
Recalling firm
Cardinal Health
Quantity
34 cases.
Distribution
Nationwide Distribution.
Recall date
October 28, 2015
Classification
Class II
Status
Terminated
Agency
FDA (device)
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