Z-0133-2016 Class II Terminated
FDA device recall Z-0133-2016 was initiated by Cardinal Health on Aug 25, 2015 and is designated Class II. 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… The recall status is terminated (terminated Aug 1, 2016). Affected quantity: 34 cases.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 28, 2015
- Initiation Date
- Aug 25, 2015
- Termination Date
- Aug 1, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 cases.
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.
Distribution Pattern
Nationwide Distribution.
Code Information
Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0133-2016
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026