Device recall
Z-0021-04: Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe…
FDA device recall · Class II · Vital Concepts, Inc.
Key facts
| Recall number (Z-number) | Z-0021-04 |
|---|---|
| Recall event | 27131 |
| Product | 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… |
| Product code | GCY |
| Recalling firm | Vital Concepts, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 12, 2004 |
| 510(k) numbers | K934382, K960616 |
| FEI number | 1000115375 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database