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Terminated

Radiation Protective Eyewear (only involving multifocals. FTC 28 Progress X-Ray Protective Eyewear Protective Eyewear is not sent with any package inserts or labeling. It is sent is plain envelope, bag of box.

FDA Recall Z-2167-2008 · Posted 2008-08-25

Recall StatusTerminated
Product CodeHOY
Date Initiated2008-06-05
Date Terminated2008-12-24
Product Quantity845 pairs of eyewear

Reason for Recall

Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.

Firm Action

Customers were all notified by phone, followed by an Urgent Recall letter dated June 3, 2008. The letter asked that customers examine their stock immediately to determine if they had any of these radiation protective bifocals on hand, discontinue use or distribution of the lot, and set the products aside for further instructions. Also, if customers distributed these items, they needed to contact their accounts and advise them of the recall and have them return their outstanding recall stock to them. The firm will send replacement products in the weeks to follow.

Root Cause

Process control

Distribution Pattern

Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands.

Official Source

View FDA Recall →

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

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