• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Recall
Phantom black latex powder-free gloves
see related information
Date Posted January 11, 2012
Recall Number Z-0712-2012
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
Reason for
Recall
The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
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.
 
-
-