Z-0133-2016Class II

Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the...

Name: Z-0133-2016 Ambitex NMD400 Nitrile Exam Gloves size medium. General Hospital and Personal use. Intended to be worn on the...
Creator: Cardinal Health
Published: 2015-08-25
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2015-08-25 / Terminated / root cause: manufacturing process

FDA source

Cardinal Health began a recall of 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... on 2015-08-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0133-2016
Classification: Class II
Status: Terminated
Initiated: 2015-08-25
Posted: 2015-10-16
Terminated: 2016-08-01
Recalling firm: Medtronic, Inc.
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 Polymer Patient Examination Glove
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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm sent an Urgent: Product Recall letter dated 8/25/2015. The firm is requesting the user discontinue using and return any remaining stock of the AMBITEX Nitrile Exam Gloves because the gloves were inadvertently shipped prior to U.S. FDA releasing them for sale. Additionally, the firm requests that the customer quarantine the affected examination gloves; and return a copy of the enclosed Acknowledgment Form confirming their receipt of the Urgent recall via fax to 216-651-9760. Customer Service should be contacted at 800-GLOVES-0 to arrange for the return and credit of any on hand product that customer may have. If the customer has further distributed the affected gloves they are advised to notify their customers of the recall.
Quantity in commerce: 34 cases.
Distribution: Nationwide Distribution.
Product codes and lots: Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0133-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0133-2016	Class II	Terminated	Voluntary: Firm initiated	2015-10-28	2015-10-16

Product code LZA

K110979Class IDermagrip Ultra Powder Free Blue Nitrile Patient Examination Gloves Non-Sterile,tested for Use W/ Chemotherapy DrugsAdvanced Medical Products Sdn Bhd / cleared 2011-10-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)