Recall Z-1132-2008 ยท HLI Ophthalmoscope, Ac-Powered
Keeler Instruments Inc
Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
| Date | May 22, 2008 (initiated Jan 8, 2008) |
| Status | Terminated |
| Reason | Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product. |
| Root cause | Process design |
| Action | Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product. |
| Quantity | 25 units |
| Distribution | The products were shipped to a distributor in NJ. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K854244 | THE KEELER ALL PUPIL INDIRECT OPHTHALMOSCOPE Keeler Instruments, Inc., Nov 12, 1985 |