Device recall
Z-0753-03: Custom surgical packs for a variety of surgical applications. Each pack is…
FDA device recall · Class II · Windstone Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0753-03 |
|---|---|
| Recall event | 25830 |
| Product | Custom surgical packs for a variety of surgical applications. Each pack is custom assembled and contains a variety of components including blades, gowns, needles, sponges, towels, syringes, gloves, etc. All products could have the WINDSTONE MEDICAL INC. label or the CARDIO-PAK label. MAJOR PACK |
| Recalling firm | Windstone Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 9, 2003 |
| 510(k) numbers | K902475, K923231, K923233 |
| FEI number | 1000125955 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
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