Device recall
Z-1959-2019: Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot…
FDA device recall · Class II · Applied Medical Resources Corp
Key facts
| Recall number (Z-number) | Z-1959-2019 |
|---|---|
| Recall event | 82986 |
| Product | Kii Fios First Entry, 5 X 75 mm, RX only, REF CFF05 Qty: 6, Sterile R, Lot: 1330981, Exp: July 15, 2021, Applied Medical Resource Corp. Product Usage: Kii Fios first entry is indicated for use in general, abdominal, gynecological and thoracic minimally invasive surgical procedures to establish a… |
| Product code | GCJ |
| Recalling firm | Applied Medical Resources Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 12, 2020 |
| 510(k) numbers | K041795, K083638 |
| FEI number | 2027111 |
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