CLASS II Device recall · Reported 28 Oct 2015 · FDA Enforcement Report
Ambitex NMD400 Nitrile Exam Gloves size medium recalled
Cardinal Health is recalling Ambitex NMD400 Nitrile Exam Gloves size medium, distributed nationwide in the US. The recall was initiated on 25 Aug 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0133-2016
- FDA event ID
- 72078
- Recalling firm
- Cardinal Health, Waukegan, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Aug 2015
- FDA classified
- 16 Oct 2015
- Reported
- 28 Oct 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Masks, Gloves & PPE
Timeline
| 25 Aug 2015 | Recall initiated by company | |
| 16 Oct 2015 | Classified by FDA | +52 days |
| 28 Oct 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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 barrier against potentially infectious materials and other contaminants.
Where it was distributed
Nationwide Distribution.
Questions about this recall
Why was it 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.
Which lots are affected?
Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
Where was it sold?
Nationwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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