Drug recall
EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile…
FDA recall event 81240 · Class II · Baxter Healthcare Corporation
Key facts
| Event ID | 81240 |
|---|---|
| Recall numbers | Z-0363-2019, Z-0364-2019, Z-0365-2019, Z-0366-2019, Z-0367-2019 |
| Recalling firm | Baxter Healthcare Corporation |
| Product type | Devices |
| Products | EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set., EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set., EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set., EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set., EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set. |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Potential ability to leak once used for compounding. |
| Initiation date | Sep 12, 2018 |
| Report date | Nov 7, 2018 |
| Termination date | Nov 2, 2020 |
| City | Deerfield |
| State | IL |
| Country | United States |
| FEI number | 1417572 |
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: