Recall Z-0258-04 ยท BYY Tube, Aspirating, Flexible, Connecting
Vital Concepts, Inc.
Irrigation aspiration system with double spike tubing and 33 cm probe, latex free, catalog # 55060. Sterile, single use. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ.
| Date | Jul 20, 2004 (initiated Nov 7, 2003) |
| Status | Terminated |
| Reason | The probe may separate from the cannula. |
| Root cause | Other |
| Action | Recall letters dated November 7, 2003 were sent to each consignee asking them to return any remaining products in inventory or in the field. |
| Quantity | 86 |
| Distribution | Arizona, Illinois, Indiana, Michigan and Pennsylvania. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K934382 | VCI SUCTION/IRRIGATION TUBING SET Vital Concepts, Inc., Feb 1, 1994 |