Device recall
Z-0487-2010: Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL…
FDA device recall · Class II · Baxter Healthcare Corp.
Key facts
| Recall number (Z-number) | Z-0487-2010 |
|---|---|
| Recall event | 53751 |
| Product | Buretrol Solution Sets, a sterile fluid pathway of 105 (2.7 m), 60 drops/mL, with 150 mL Burette Drip Chamber Filter Valve, 2 injection Y-sites, 3 Luer Activated Valves and Male Luer Lock Adapter with Retractable Collar; 48 individually pouched sterile sets per case; Baxter Healthcare Corporation… |
| Product code | FPA |
| Recalling firm | Baxter Healthcare Corp. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 8, 2010 |
| 510(k) numbers | K984381 |
| FEI number | 1416980 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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