Device recall
Z-1455-2014: Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model…
FDA device recall · Class II · Gambro Renal Products, Incorporated
Key facts
| Recall number (Z-number) | Z-1455-2014 |
|---|---|
| Recall event | 67797 |
| Product | Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport… |
| Product code | FJK |
| Recalling firm | Gambro Renal Products, Incorporated |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 22, 2015 |
| FEI number | 1713683 |
At a glance
- None 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