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.
Reported: October 28, 2015 Initiated: August 25, 2015 #Z-0133-2016
Product Description
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.
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.
Details
- Recalling Firm
- Cardinal Health
- Units Affected
- 34 cases.
- Distribution
- Nationwide Distribution.
- Location
- Waukegan, IL
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cardinal Health. Units affected: 34 cases..
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2015. Severity: Moderate. Recall number: Z-0133-2016.
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