Device recall
Z-1484-2017: AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to…
FDA device recall · Class II · Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1484-2017 |
|---|---|
| Recall event | 76607 |
| Product | AMS-636, 60" Microbore extension set. Product Usage: Accessory devices used to administer medical fluids. |
| Product code | FPA |
| Recalling firm | Vygon MFG, Inc., dba/ Churchill Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 22, 2019 |
| 510(k) numbers | K021395 |
| FEI number | 1000120555 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1,000+ 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