Device recall
Z-0511-2024: 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML…
FDA device recall · Class I · Nurse Assist, LLC
Key facts
| Recall number (Z-number) | Z-0511-2024 |
|---|---|
| Recall event | 93434 |
| Product | 0.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC MEDICAL: 10ML FILL SYRINGE/9210; NURSE ASSIST: 3ML IV FLUSH SYRINGE/1203-BP, 5ML IV FLUSH SYRINGE/1205-BP, 10ML IV FLUSH SYRINGE/1210-BP; SOL: 0.9% SODIUM CHLORIDE IV FLUSH SYRINGE/PFF001; HALYARD OWENS MINOR: 0.9% USP SODIUM CHLORIDE… |
| Product code | NGT |
| Recalling firm | Nurse Assist, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K030813, K083042, K201286 |
| FEI number | 3002695476 |
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