notyard
09-04-2008, 09:57 AM
FDA class III recall:
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 in plain envelope, bag or box. 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, Recall # Z-2167-2008
CODE
All radiation protective bifocals
RECALLING FIRM/MANUFACTURER
Phillips Safety Products, Middles e x, NJ, by telephone and letter dated June 3, 2008. Firm initiated recall is ongoing.
REASON
Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
VOLUME OF PRODUCT IN COMMERCE
845 pairs
DISTRIBUTION
Nationwide and Internationally
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 in plain envelope, bag or box. 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, Recall # Z-2167-2008
CODE
All radiation protective bifocals
RECALLING FIRM/MANUFACTURER
Phillips Safety Products, Middles e x, NJ, by telephone and letter dated June 3, 2008. Firm initiated recall is ongoing.
REASON
Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling.
VOLUME OF PRODUCT IN COMMERCE
845 pairs
DISTRIBUTION
Nationwide and Internationally