Device recall
Z-1327-2015: Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary…
FDA device recall · Class II · Ameda, Inc.
Key facts
| Recall number (Z-number) | Z-1327-2015 |
|---|---|
| Recall event | 70599 |
| Product | Ameda Dual Short Term HygieniKit Milk Collections System (SKU 17115) - Primary packaging is 12 pouches with Tyvek header (10.75 x 16.375 x 3") within a secondary corrugated shipper (20.75 x 15.50 x 8.5" inner dimensions). The device is intended to be connected to a powered breast pump or adapted for… |
| Product code | HGY |
| Recalling firm | Ameda, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2017 |
| 510(k) numbers | K011519 |
| FEI number | 3009974348 |
At a glance
- 1–9 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