Recall Z-0021-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Vital Concepts, Inc.
Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucs
| Date | Oct 15, 2003 (initiated Jul 11, 2003) |
| Status | Terminated |
| Reason | The suction valve may become stuck in the 'suction on' position under vacuum. |
| Root cause | Other |
| Action | A request for product return was sent to each customer beginning on July 11, 2003. |
| Quantity | 2333 |
| Distribution | Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan |
| FDA record | Open on fda.gov |