Device recall
Z-0513-2024: Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML…
FDA device recall · Class I · Nurse Assist, LLC
Key facts
| Recall number (Z-number) | Z-0513-2024 |
|---|---|
| Recall event | 93434 |
| Product | Sterile Water/Saline: Brand Name: Product Name/Product Code: CARDINAL: 100ML STERILE SALINE BOTTLE/1020, 100ML STERILE SALINE BOTTLE/1022, 100ML STERILE WATER BOTTLE/1024, 100ML STERILE WATER BOTTLE/10000, 100ML STERILE WATER BOTTLE/PT00103419, 100ML STERILE SALINE BOTTLE/PT00103427; COVIDIEN… |
| Product code | FRO |
| Recalling firm | Nurse Assist, LLC |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K083042 |
| 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