Device recall
Z-0529-2021: CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion…
FDA device recall · Class II · CME America, LLC
Key facts
| Recall number (Z-number) | Z-0529-2021 |
|---|---|
| Recall event | 86047 |
| Product | CME America T-Syringe Pump - Ameritus 1st Enteral Pump - Product Usage: infusion of medications or fluids requiring continuous or intermittent delivery at precisely-controlled infusion rates through clinically acceptable routes of administration, including intravenous, subcutaneous, percutaneous… |
| Product code | FRN |
| Recalling firm | CME America, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 8, 2022 |
| 510(k) numbers | K080954 |
| 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