Device recall
Z-0804-2018: STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration…
FDA device recall · Class II · ConMed Corporation
Key facts
| Recall number (Z-number) | Z-0804-2018 |
|---|---|
| Recall event | 79129 |
| Product | STAT 2 I.V. Gravity Flow Controller and STAT 2 Primary, Secondary Administration Sets and Extension Sets (Catalog Numbers: (1) S2, STAT 2 I.V. Controller, (2) S2-12, STAT 2 Extension Set Gravity Flow Controller, 12 length, (3) S2-20 MD, STAT 2 Secondary Set Gravity Flow Controller, 20 Drops/ml, 13… |
| Product code | LDR |
| Recalling firm | ConMed Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 25, 2022 |
| 510(k) numbers | K905498 |
| FEI number | 3001451571 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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