Recall Z-0020-04 ยท GCY Apparatus, Suction, Single Patient Use, Portable, Nonpowered
Vital Concepts, Inc.
Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
| 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 | 252 |
| Distribution | Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan |
| FDA record | Open on fda.gov |