Device recall
Z-0842-2012: Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22…
FDA device recall · Class III · Terumo Cardiovascular Corporation
Key facts
| Recall number (Z-number) | Z-0842-2012 |
|---|---|
| Recall event | 60475 |
| Product | Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gases between extracorporeal blood and a gaseous environment during cardiopulmonary bypass procedures… |
| Product code | DTZ |
| Recalling firm | Terumo Cardiovascular Corporation |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 29, 2012 |
| 510(k) numbers | K993772 |
| FEI number | 3000204839 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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