Device 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.
Z-0133-2016
Product summary
- Firm
- Cardinal Health
- Event
- Event 72078
- Status
- Terminated
- Classification
- Class II
- Quantity
- 34 cases.
- Official record key
device-enforcement:Z-0133-2016
Official wording
Reason: 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.
Code information: Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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.