Recall Z-0476-2009 ยท GCJ Laparoscope, General & Plastic Surgery
CTS, Inc. dba Guidant Cardiac Surgery
VASOVIEW 4 Endoscopic Vessel Harvesting System, with VASOVIEW Flexible Endoscopic Tools in the following configurations: VH-10242: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic scissors; and VH-10243: Uniport plus dissection cannula, short port blunt tip trocar, flexible endoscopic bisector.
| Date | Dec 23, 2008 (initiated Sep 9, 2008) |
| Status | Terminated |
| Reason | Packaging unsealed: Sterility of product may be compromised due to packaging issue. For further information, please contact the firm at 408-635-6874. |
| Root cause | Packaging process control |
| Action | The firm issued a letter entitled "URGENT FIELD ACTION - IMMEDIATE ACTION REQUIRED *** VASOVIEW(TM) 4 Endoscopic Vessel Harvesting System (Kit Only)" via federal express to its consignees on September 9, 2008. The firm has asked its consignees to return the product. Follow-up calls were made to ensure recall effectiveness. |
| Quantity | 7,935 units |
| Distribution | Worldwide Distribution --- including USA and country of Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.