Device recall
Z-0361-2016: Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat…
FDA device recall · Class II · Quest Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0361-2016 |
|---|---|
| Recall event | 72524 |
| Product | Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volume Delivery Set for use with cardiopulmonary bypass equipment. |
| Product code | DTR |
| Recalling firm | Quest Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 17, 2016 |
| 510(k) numbers | K953838 |
| FEI number | 3001665800 |
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