Device recall
Z-1442-2020: BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime…
FDA device recall · Class I · CME America, LLC
Key facts
| Recall number (Z-number) | Z-1442-2020 |
|---|---|
| Recall event | 84985 |
| Product | BodyGuard Microset REF A120-003XYVA, Sterile EO, Tubing: 150 in. (380 cm), Prime Vol: approx. 8ml Product Usage: The BodyGuard Infusion Pump System is designed to transfer medication and fluids intravenously. |
| Product code | FRN |
| Recalling firm | CME America, LLC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Apr 13, 2022 |
| 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