Device recall
Z-0827-2008: Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium…
FDA device recall · Class I · AM2 PAT INC
Key facts
| Recall number (Z-number) | Z-0827-2008 |
|---|---|
| Recall event | 46182 |
| Product | Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-01, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, 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 |
| 510(k) numbers | K032417 |
| FEI number | 3001574774 |
At a glance
- 1–9 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