Device recall
Z-0842-2019: Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial…
FDA device recall · Class II · Smiths Medical ASD Inc.
Key facts
| Recall number (Z-number) | Z-0842-2019 |
|---|---|
| Recall event | 80829 |
| Product | Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325… |
| Product code | JKA |
| Recalling firm | Smiths Medical ASD Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K952516 |
| 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