Recall Z-0197-2009 ยท KDD Kit, Surgical Instrument, Disposable
DeRoyal Industries Inc
DeRoyal Lap Appy TraceCart, REF53-1776, Rx only, non-sterile. (custom surgical kit)
| Date | Nov 7, 2008 (initiated Oct 1, 2008) |
| Status | Terminated |
| Reason | Surgical kits contained a recalled Endopath ETX 35 mm Endoscopic Linear Cutter White Reload/Cartridges. |
| Root cause | Nonconforming Material/Component |
| Action | The firm sent out recall notices to their sales representatives, the distributors, and the hospitals addressed to the Recall Coordinator/OR Supervisor on 10/2/08. These notices stated that the recalling firm's sales representatives would perform the field correction in lieu of returning the kits. Contact DeRoyal Industries, Inc. at 1-865-362-6157 for assistance. |
| Quantity | 4 kits |
| Distribution | LA & KY |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.