Device recall
Z-0187-2007: ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF…
FDA device recall · Class II · Sorenson Medical, Inc.
Key facts
| Recall number (Z-number) | Z-0187-2007 |
|---|---|
| Recall event | 36505 |
| Product | ambIT Ambulatory Infusion Pump Cassette; Filter, Male, Sterile, Vol. 2.3ml, REF 220266, Sorenson Medical, Inc., West Jordan, Utah. |
| Product code | FRN |
| Recalling firm | Sorenson Medical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 26, 2011 |
| 510(k) numbers | K002434, K033325, K052221 |
| FEI number | 1000117099 |
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