Device recall
Z-0321-2018: UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z…
FDA device recall · Class II · King Systems Corp. dba Ambu, Inc.
Key facts
| Recall number (Z-number) | Z-0321-2018 |
|---|---|
| Recall event | 78799 |
| Product | UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D465-61Z, JD365-6033Z, DF370-6121Z, DF3110-61Z, DF375-17621Z, DF375-6121Z, DF475-17621Z, DF370-6121Z… |
| Product code | CAH |
| Recalling firm | King Systems Corp. dba Ambu, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 17, 2018 |
| 510(k) numbers | K973797 |
| FEI number | 1824226 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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