Recall Z-1205-2007 ยท KDD Kit, Surgical Instrument, Disposable
DeRoyal Lafollette
Assorted non- sterile Tracecarts (with sterile component(s)); DeRoyal C-Section Tracecart, REF 53-1746.02, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracepak, REF 90-2838.11, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal CABG Tracecart, REF 53-1865.03, non-sterile, Rx only, DeRoyal, Powell, TN 37849; DeRoyal Thoracotomy Tracecart 1/CS, REF 53-0464.13, non-sterile,
| 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 | 112 cases |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.