Device recall
Z-0818-2020: VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage…
FDA device recall · Class II · Greiner Bio-One North America, Inc.
Key facts
| Recall number (Z-number) | Z-0818-2020 |
|---|---|
| Recall event | 84536 |
| Product | VACUETTE TUBE, 3.5mL CAL Serum Sep Clot Activator, REF 454067P - Product Usage: VACUETTE Tubes, Holders, and Needles are use together as a system for the collection of venous blood. VACUETTE tubes are used to collect, transport, and process blood for testing serum, plasma, or whole blood in the… |
| Product code | JKA |
| Recalling firm | Greiner Bio-One North America, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Oct 5, 2020 |
| 510(k) numbers | K983952 |
| FEI number | 3001451379 |
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