Device recall
Z-1077-05: Labeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM…
FDA device recall · Class II · Argon Medical Devices, Inc
Key facts
| Recall number (Z-number) | Z-1077-05 |
|---|---|
| Recall event | 32510 |
| Product | Labeling is as follows: Product Labeling: ''***Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO. 194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/ MLL***1 72'' Vented Spike Line***1 10cc Control Syringe***1 M/F L/L PVC Line*** 1 Stopcock… |
| Product code | IZI |
| Recalling firm | Argon Medical Devices, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 19, 2007 |
| 510(k) numbers | K911732 |
| FEI number | 1625425 |
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