Device recall
Z-3196-2018: Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases…
FDA device recall · Class III · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-3196-2018 |
|---|---|
| Recall event | 80632 |
| Product | Portex Pulsator Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, REF 4080P-2, Sterile, RX. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH. |
| Product code | JKA |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Oct 19, 2018 |
| 510(k) numbers | K981035 |
| FEI number | 3012307300 |
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