Device recall
Z-1126-2015: BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS…
FDA device recall · Class II · CME America, LLC
Key facts
| Recall number (Z-number) | Z-1126-2015 |
|---|---|
| Recall event | 70294 |
| Product | BodyGuard 323 pump, models 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, 100-603XSA and 100-603XSAP |
| Product code | FRN |
| Recalling firm | CME America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 31, 2017 |
| 510(k) numbers | K042696 |
| FEI number | 3006967710 |
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