Cardinal Health: Medical Device Recall in 2015 - (Recall #: Z-0133-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: August 25, 2015

Date Posted: October 28, 2015

Recall Number: Z-0133-2016

Event ID: 72078

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.

Status: Terminated

Product Quantity: 34 cases.

Code Information:

Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated