Device recall
Z-0233-2016: Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling…
FDA device recall · Class II · Utah Medical Products, Inc
Key facts
| Recall number (Z-number) | Z-0233-2016 |
|---|---|
| Recall event | 72462 |
| Product | Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage. |
| Product code | KDD |
| Recalling firm | Utah Medical Products, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 2, 2016 |
| 510(k) numbers | K821814 |
| FEI number | 1718873 |
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