Device recall
Z-0831-2008: Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2…
FDA device recall · Class I · AM2 PAT INC
Key facts
| Recall number (Z-number) | Z-0831-2008 |
|---|---|
| Recall event | 46182 |
| Product | Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501 |
| Product code | FOZ |
| Recalling firm | AM2 PAT INC |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Dec 2, 2010 |
| FEI number | 3001574774 |
At a glance
- None Linked 510(k)s
- 10–99 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