Recall Z-0133-2016— Cardinal Health

Name: FDA recall Z-0133-2016
Creator: U.S. Food and Drug Administration
Published: 2015-08-25

Class II · Terminated

Class II FDA medical device recall by Cardinal Health, initiated 2015-08-25, terminated 2016-08-01. It names one FDA 510(k) clearance: K110979. 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.. 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..

Recalling firm: Cardinal Health
Classification: Class II
Status: Terminated
Initiated: 2015-08-25
Terminated: 2016-08-01
Firm location: Waukegan, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K110979 — DERMAGRIP ULTRA POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES NON-STERILE,TESTED FOR USE W/ CHEMOTHERAPY DRUGSAdvanced Medical Products Sdn Bhd·cleared 2011-10-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.