Device recall
Z-2213-2015: Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar…
FDA device recall · Class II · EXP Pharmaceutical Services Corp
Key facts
| Recall number (Z-number) | Z-2213-2015 |
|---|---|
| Recall event | 71608 |
| Product | Medical Device Exchange - KII FIOS FIRST ENTRY 5X100MM; Pouch, Tyvek/Mylar, Sterile, Single Use Only; OEM Catalog number CFF03 EXP (repackager), Applied Medical (OEM) Laparoscope, General & Plastic Surgery. |
| Product code | GCJ |
| Recalling firm | EXP Pharmaceutical Services Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 30, 2015 |
| FEI number | 3004376386 |
At a glance
- None Linked 510(k)s
- 10–99 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