Recall Z-2167-2008 ยท HOY Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Phillips Safety Products
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.
| Date | Aug 25, 2008 (initiated Jun 5, 2008) |
| Status | Terminated |
| Reason | Radiation Protective Eyewear does not meet the radiation protection levels stated on the labeling. |
| Root cause | 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 | 845 pairs of eyewear |
| Distribution | Worldwide Distribution --- including USA and countries of Spain, Norway, Great Britain and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.