Device recall
Z-2178-2013: Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill…
FDA device recall · Class II · Covidien LLC
Key facts
| Recall number (Z-number) | Z-2178-2013 |
|---|---|
| Recall event | 65978 |
| Product | Monoject 0.9% Sodium Chloride Flush Syringe, 12 mL Syringe with 10 mL Fill Product ID: 8881570121 Product Usage: Both 0.9% Sodium Chloride Flush syringes and 10U/mL or 100U/mL Heparin Lock Flush syringes are sterile, single-use products which are intended for use in flushing and locking compatible… |
| Product code | NGT |
| Recalling firm | Covidien LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 21, 2015 |
| 510(k) numbers | K032438 |
| FEI number | 1282497 |
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