Device recall
Z-0419-2015: Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF…
FDA device recall · Class II · Gyrus Acmi, Incorporated
Key facts
| Recall number (Z-number) | Z-0419-2015 |
|---|---|
| Recall event | 69584 |
| Product | Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 005280-901 (with 8 mm Disposable Trocan). Sterile EO. Single Use Only. The disposable Falope-Ring Band Applicator is a sterile, two-band, dual-incision instrument. The two-band applicator enables the physician to occlude… |
| Product code | KNH |
| Recalling firm | Gyrus Acmi, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 3, 2017 |
| PMA numbers | P870076 |
| FEI number | 3003790304 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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