Device recall
Z-1886-2020: BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in…
FDA device recall · Class II · CME America, LLC
Key facts
| Recall number (Z-number) | Z-1886-2020 |
|---|---|
| Recall event | 85206 |
| Product | BodyGuard Microset For Use with the BodyGuard Infusion Pump *** Tubing: 110 in. (280 cm) - Blue Stripe - Product Usage: The system is intended for patients who require maintenance medications, PCA therapy, parenteral nutritional fluids, and general IV fluid therapy in hospital and home care… |
| Product code | FPA |
| Recalling firm | CME America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 27, 2021 |
| 510(k) numbers | K031749 |
| FEI number | 3006967710 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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