Device recall
Z-1326-2015: Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches…
FDA device recall · Class II · Ameda, Inc.
Key facts
| Recall number (Z-number) | Z-1326-2015 |
|---|---|
| Recall event | 70599 |
| Product | Ameda One-Hand Manual Breast Pump (SKU 17161) - Primary packaging is 6 pouches with Tyvek header (9.5 x 13.63 x 3.75") within a secondary corrugated shipper (16 x 11.02 x 5.12" inner dimensions). The device is indicated for assisted expression of milk using manual suction. |
| Product code | HGY |
| Recalling firm | Ameda, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 21, 2017 |
| 510(k) numbers | K912355 |
| 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