Device recall

Z-0133-2016: Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal…

FDA device recall · Class II · Cardinal Health

Key facts

Recall number (Z-number) Z-0133-2016
Recall event 72078
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.
Product code LZA
Recalling firm Cardinal Health
Recall class Class II
Status Terminated
Termination date Aug 1, 2016
510(k) numbers K110979
FEI number 3001236905

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 10–99 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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