Device recall
Z-1032-2015: HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP…
FDA device recall · Class II · Fresenius Kabi USA, LLC
Key facts
| Recall number (Z-number) | Z-1032-2015 |
|---|---|
| Recall event | 70050 |
| Product | HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710 |
| Product code | NZW |
| Recalling firm | Fresenius Kabi USA, LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jan 26, 2016 |
| 510(k) numbers | K092938 |
| FEI number | 3002733956 |
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