Device recall
Z-0053-2020: Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip…
FDA device recall · Class II · Arrow International Inc
Key facts
| Recall number (Z-number) | Z-0053-2020 |
|---|---|
| Recall event | 82984 |
| Product | Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access |
| Product code | FOZ |
| Recalling firm | Arrow International Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 24, 2020 |
| 510(k) numbers | K900263 |
| FEI number | 3015859709 |
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