FDA Recall 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.

Recall: Z-2167-2008 · Initiated June 5, 2008

Recall

Recall Number
Z-2167-2008
Event Number
48611
Firm
Phillips Safety Products
FEI Number
3004183518
Product Code
HOY
Status
Terminated
Root Cause
Process control
Initiated
June 5, 2008
Posted
August 25, 2008
Terminated
December 24, 2008
Address
123 Lincoln Blvd, Middlesex, NJ, 08846-1071

Description

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.

Reason

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

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.

Distribution

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

Quantity

845 pairs of eyewear