Device recall
Z-0195-2018: ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List…
FDA device recall · Class II · ICU Medical Inc
Key facts
| Recall number (Z-number) | Z-0195-2018 |
|---|---|
| Recall event | 78418 |
| Product | ICU Mednet(TM) Medication Management Suite 6.1 and 6.21, Product Code/List Numbers: (a) 16037-64-01; MedNet 6.1 b) 16037-64-02; MedNet 6.1 c) 16037-64-03; MedNet 6.1 d) 16037-64-04; MedNet 6.21 The ICU Medical MedNet Medication Management Suite (MMS) is intended to facilitate networked communication… |
| Product code | FRN |
| Recalling firm | ICU Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 3, 2020 |
| 510(k) numbers | K141102 |
| FEI number | 3013319212 |
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