Device recall
Z-1038-2019: FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter…
FDA device recall · Class II · ConvaTec, Inc
Key facts
| Recall number (Z-number) | Z-1038-2019 |
|---|---|
| Recall event | 82039 |
| Product | FilterFlow Suction Handle CH24, 20 eaches per sales unit. Product Usage: Filter Flow is designed for orthopedic surgery and combines suctioning function with filtering. The device is intended for orthopedic surgical procedures to remove and collect debris and bone fragments, chips, cement, marrow… |
| Product code | JOL |
| Recalling firm | ConvaTec, Inc |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3011987967 |
At a glance
- None 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