Device recall
Z-0939-2025: ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP…
FDA device recall · Class II · Sklar Instruments
Key facts
| Recall number (Z-number) | Z-0939-2025 |
|---|---|
| Recall event | 95946 |
| Product | ECONO STERILE medical procedure kits labeled as: 1) ECONO STERILE ROCH-PEAN FCP 8" CVD CS/25,Model Number 94-0286; 2) ECONO STERILE DRESSING FCP 5.5" CS/25LG,Model Number 94-0290; 3) ECONO STERILE TISSUE FCP 1X2 5.5" STER CS25,Model Number 94-0291; 4) ECONO STERILE FRCPS JANSEN BAYO STRL6.25… |
| Product code | GEN |
| Recalling firm | Sklar Instruments |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K772229, K801273 |
| FEI number | 2523865 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 10–99 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