Drug recall
BD Vacutainer¿ K2 EDTA (K2E) 3.6mg Blood Collection Tube (13 x 75 mm x 2.0 mL). Catalog Number: 367841. Used…
FDA recall event 79041 · Class II · Becton Dickinson & Company
Key facts
| Event ID | 79041 |
|---|---|
| Recall numbers | Z-0968-2018 |
| Recalling firm | Becton Dickinson & Company |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | A limited portion of the lot was manufactured with less than the required amount of K2EDTA additive, an anticoagulant, which may cause erroneous results that could lead to specimen recollection and… |
| Initiation date | Aug 29, 2017 |
| Report date | Mar 21, 2018 |
| Termination date | May 16, 2019 |
| City | Franklin Lakes |
| State | NJ |
| Country | United States |
| FEI number | 2243072 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: