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U.S. Department of Health and Human Services

Class 2 Device Recall Phantom black latex powderfree gloves

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 Class 2 Recall
Phantom black latex powderfree gloves
see related information
Date Posted January 11, 2012
Recall Status1 Terminated on May 29, 2012
Recall Number Z-0712-2012
Recall Event ID 60894
Premarket Notification
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
Recalling Firm/
Manufacturer
Adenna Inc
201 S Milliken Ave
Ontario, California 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 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Release of Mat./Comp. prior to 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LYY and Original Applicant = TEKMEDIC (M) SDN BHD
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