Recall Z-2399-2010 ยท HQF Laser, Ophthalmic
Peregrine Surgical Ltd
Peregrine 20 GA Endo Ocular Adjustable Laser Probe
| Date | Sep 11, 2010 (initiated Jul 19, 2010) |
| Status | Terminated |
| Reason | Product did not have proper 510(k) clearance |
| Root cause | Other |
| Action | A recall letter is being sent to all affected accounts with instructions to return the recalled product to the recalling firm. |
| Quantity | 132 boxes |
| Distribution | Product was distributed to hospitals and eye surgery centers in Florida, Maryland, Missouri, North Carolina, Ohio, Pennsylvania, Texas. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.