Device recall
Z-0119-2022: Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121…
FDA device recall · Class I · Windstone Medical Packaging, Inc.
Key facts
| Recall number (Z-number) | Z-0119-2022 |
|---|---|
| Recall event | 88802 |
| Product | Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions Custom Convenience Kits: AMS-9041CP Leaderflex Insertion Kit with Ultrasound, AMS-9046CP-1 Insertion Tray-RX, AMS8939A Universal Procedure Pack w/Split Drape, AMS9957A Port… |
| Product code | NGT |
| Recalling firm | Windstone Medical Packaging, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K032438 |
| FEI number | 1000125955 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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