Class 2 Device Recall Ambitex NMD400 Nitrile Exam Gloves

• Date Initiated by Firm: August 25, 2015
• Create Date: October 16, 2015
• Recall Status: Terminated on August 01, 2016
• Recall Number: Z-0133-2016
• Recall Event ID: 72078
• 510(K)Number: K110979
• Product Classification: Polymer patient examination glove - Product Code LZA
• 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.
• Code Information: Ambitex NMD400 Nitrile Exam Glove LOT NUMBER: 25314
• FEI Number: 3001236905
• Recalling Firm/ Manufacturer: Cardinal Health; 1300 Waukegan Rd; Waukegan IL 60085-6724
• For Additional Information Contact: Michele Donatich; 847-887-6412
• Manufacturer 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.
• FDA Determined 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZA