Device recall
Z-0352-2023: Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a)…
FDA device recall · Class I · ARROW INTERNATIONAL Inc.
Key facts
| Recall number (Z-number) | Z-0352-2023 |
|---|---|
| Recall event | 91090 |
| Product | Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-PCCH2, h) ASK-45703-PN; catheter introducer |
| Product code | FOZ |
| Recalling firm | ARROW INTERNATIONAL Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 7, 2024 |
| 510(k) numbers | K002507, K071538 |
| FEI number | 3013162291 |
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