Home / Recalls / Medical Devices
Baxter Healthcare Corp. recalls Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Recalled July 3, 2013 · FDA recall Z-1606-2013 · Baxter Healthcare
Hazard
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 improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field. · FDA Class II
Units
3,255,096 total
Sold at
Distributed Nationwide and in Puerto Rico.
Description
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 improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.
Product
Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications.
Manufacturer(s)
Baxter Healthcare Corp.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →