Device recall
Z-1950-2019: ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use…
FDA device recall · Class II · Helena Laboratories, Corp.
Key facts
| Recall number (Z-number) | Z-1950-2019 |
|---|---|
| Recall event | 83088 |
| Product | ColoCARE, Cat. No. 5651, packaged 50 envelopes/box, For In-Vitro Diagnostic Use. The firm name on the label is Helena Laboratories, Beaumont, TX. |
| Product code | KHE |
| Recalling firm | Helena Laboratories, Corp. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K882799 |
| FEI number | 1618982 |
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