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U.S. Department of Health and Human Services

Class 3 Device Recall Radiation Protective Eyewear

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  Class 3 Device Recall Radiation Protective Eyewear see related information
Date Initiated by Firm June 05, 2008
Date Posted August 25, 2008
Recall Status1 Terminated 3 on December 24, 2008
Recall Number Z-2167-2008
Recall Event ID 48611
Product Classification Ophthalmic eye shield - Product Code HOY
Product 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.
Code Information ALL radiation protective bifocals, both progressive and FT28 - product numbers: PX-PROG, PX-FT28, FB-103-RXB, FB-500-RXB, FB-100-SRXB, FB-100-BRXB, FB-100-CRXB, FB-108-SRXB, FB-108-BRXB, RGS-97RX-BI, SFFT X-RAY, RGS-53-BI, LT-53-RXP, RG-500-SRG1.5, RG-500-SRG2.0.
Recalling Firm/
Manufacturer
Phillips Safety Products
123 Lincoln Blvd
Middlesex NJ 08846-1071
For Additional Information Contact Keiran Hunt
732-356-1493
Manufacturer Reason
for Recall
Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
FDA Determined
Cause 2
Process control
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.
Quantity in Commerce 845 pairs of eyewear
Distribution Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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