Recall Z-1204-2007 ยท KDD Kit, Surgical Instrument, Disposable
DeRoyal Lafollette
Assorted sterile surgical kits/ trays: DeRoyal Neuro Tray, REF 89-4502.05, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal D/C LEEPS, Hysteroscopes 80015, REF 89-4915.02, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal ACF Tray, REF 50-11919.13, sterile, Rx only, assembled in Mexico for DeRoyal, Powell, TN 37849; DeRoyal Ortho III, REF
| Date | Aug 29, 2007 (initiated Jul 3, 2007) |
| Status | Terminated |
| Reason | Packaging failure. Lack of sterility assurance |
| Root cause | Other |
| Action | Written notification of the recall was sent (via UPS Ground) beginning 7/03/2007 to consignees to advise them of problem and the recall. The letter stated that the recall was to the User level (which in this case, are the hospitals) and requested return of the product. |
| Quantity | 2023 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.