Class 2 Device Recall Phantom black latex powderfree gloves

• Date Initiated by Firm: December 22, 2011
• Date Posted: January 11, 2012
• Recall Status: Terminated on May 29, 2012
• Recall Number: Z-0712-2012
• Recall Event ID: 60894
• 510(K)Number: K100694
• Product Classification: Latex patient examination glove - Product Code LYY
• Product: Phantom-brand Black Latex Powder Free Examination Gloves, 100 gloves by weight, size small and Medium, Product Code PHM912, Lot No. 002-E1LF302-1, Manufacture date JUL 2011, Size Small Product Code PHM915, Lot No. 002-E1LF305-1, Manufacture date JUL 2011, Size Medium Examination Disposable Gloves
• Code Information: Lot No. 002-E1LF302-1 and Lot No. 002-E1LF305-1
• FEI Number: 3000719089
• Recalling Firm/ Manufacturer: Adenna Inc; 201 S Milliken Ave; Ontario CA 91761-7832
• For Additional Information Contact: Charles Chang; 909-510-6999
• Manufacturer Reason for Recall: The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
• FDA Determined Cause: Release of Material/Component prior to receiving test results
• Action: Adenna Inc. sent a recall letter dated December 22, 2011, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to examine their inventory and quarantine the products that are subject to the recall. Customers were instructed to notify their customers if they have further distributed the products. Customers were instructed to cease using the recalled products, and Adenna will replace the products. Customers were instructed to complete and return the enclosed response form as soon as possible. Customers with any questions can contact their account manager at (888) 3ADENNA (1-888-323-3662) for futher assistance.
• Quantity in Commerce: 427 cartons
• Distribution: Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL.
• 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 = LYY