Device recall
Z-0968-2018: BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL)…
FDA device recall · Class II · Becton Dickinson & Company
Key facts
| Recall number (Z-number) | Z-0968-2018 |
|---|---|
| Recall event | 79041 |
| Product | BD Vacutainer K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used for whole blood hematology determinations, immunohematology testing and blood donor screening. |
| Product code | JKA |
| Recalling firm | Becton Dickinson & Company |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 16, 2019 |
| 510(k) numbers | BK050036, K981013 |
| FEI number | 2243072 |
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