FDA Enforcement
Class II
Terminated
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.
Recall: Z-0133-2016
·
Reported October 28, 2015
Enforcement
- Recall Number
- Z-0133-2016
- Event ID
- 72078
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Cardinal Health
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 28, 2015
- Initiation Date
- August 25, 2015
- Classification Date
- October 16, 2015
- Termination Date
- August 1, 2016
- Address
- 1300 Waukegan Rd, N/A, Waukegan, IL, 60085-6724, United States
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
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 Info
Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
Distribution
Nationwide Distribution.
Quantity
34 cases.