HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile,
FDA device recall Z-0022-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Vital Concepts, Inc.
- Reason for recall
- The suction valve may become stuck in the 'suction on' position under vacuum.
- Action taken
- A request for product return was sent to each customer beginning on July 11, 2003.
- Root cause
- Other
- Status
- Terminated
- Product code
- GCY
- Quantity affected
- 196
- Distribution
- Arizona, Illinois, Indiana, Michigan, Ohio, Pennsylvania, South Carolina, Texas, Utah, Washington, Canada, Israel and Japan
- Date initiated
- 2003-07-11
- Date posted
- 2003-10-15
- Date terminated
- 2004-04-12
- Location
- Grand Rapids, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VITAFLOW SUCTION/ASPIRATION TUBING SET (K960616) | Vital Concepts, Inc. | 1996-05-06 |
| VCI SUCTION/IRRIGATION TUBING SET (K934382) | Vital Concepts, Inc. | 1994-02-01 |