Drug recall
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
FDA recall event 65365 · Class II · Baxter Healthcare Corp.
Key facts
| Event ID | 65365 |
|---|---|
| Recall numbers | Z-1600-2013, Z-1601-2013, Z-1602-2013, Z-1603-2013, Z-1604-2013, Z-1605-2013, Z-1606-2013 |
| Recalling firm | Baxter Healthcare Corp. |
| Product type | Devices |
| Products | Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications., Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications., Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications., Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications., Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications. and 1 more |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process… |
| Initiation date | Jun 7, 2013 |
| Report date | Jul 3, 2013 |
| Termination date | Jun 4, 2014 |
| City | Round Lake |
| State | IL |
| Country | United States |
| FEI number | 1416980 |
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: