FDA Recall Terminated

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

Recall: Z-0712-2012 · Initiated December 22, 2011

Recall

Recall Number
Z-0712-2012
Event Number
60894
Firm
Adenna Inc
FEI Number
3000719089
Product Code
LYY
Status
Terminated
Root Cause
Release of Material/Component prior to receiving test results
Initiated
December 22, 2011
Posted
January 11, 2012
Terminated
May 29, 2012
Address
201 S Milliken Ave, Ontario, CA, 91761-7832

Description

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

Reason

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.

Distribution

Nationwide Distribution including the states of: FL, CA, NY, NV, NC, MD, TX, OR, AZ, OH, MN, and IL.

Quantity

427 cartons