Device recall
Z-0616-2018: Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express…
FDA device recall · Class III · AMEDA, INC.
Key facts
| Recall number (Z-number) | Z-0616-2018 |
|---|---|
| Recall event | 78237 |
| Product | Purely Yours Breast Pump. Model 17070PMW and Model 17070ACA. Intended to express and collect the mother s milk from the breasts of a nursing woman for the purpose of feeding the collected milk to a baby. |
| Product code | HGX |
| Recalling firm | AMEDA, INC. |
| Recall class | Class III |
| Status | Open, Classified |
| 510(k) numbers | K973501 |
| 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