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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

FDA Recall Z-0712-2012 · Posted 2012-01-11

Recalling FirmAdenna Inc
Recall StatusTerminated
Product CodeLYY
Date Initiated2011-12-22
Date Terminated2012-05-29
Product Quantity427 cartons

Reason for Recall

The recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.

Firm 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.

Root Cause

Release of Material/Component prior to receiving test results

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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