Cardinal Health Recalls Ambitex NMD400 Nitrile Exam Gloves Due to Leak Test Failure
Cardinal Health is recalling Ambitex NMD400 Nitrile Exam Gloves (size medium) because samples failed FDA water leak tests, compromising their barrier function.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device that failed a critical safety test (water leak), creating a risk of exposure to infectious materials. This fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health is voluntarily recalling 34 cases of Ambitex NMD400 Nitrile Exam Gloves, size medium. The product is intended for general hospital and personal use to provide a barrier against potentially infectious materials and other contaminants.
The recall was initiated because the product was inadvertently placed into commerce while under an FDA Exam Hold. Samples pulled from a shipment manufactured by the firm failed the water leak test required by 21 CFR 800.20. The affected lot number is 25314.
The product was distributed nationwide. Consumers and healthcare facilities should stop using the recalled gloves and contact Cardinal Health for further instructions.
The recalled product
- 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 barrier against potentially infectious materials and other contaminants.
- Manufacturer
- Cardinal Health
- Category
- Medical Device — Exam Gloves
- Affected units
- 34
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
Distribution
Distributed nationwide across the United States.
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