FDA (Devices) recall action 65365
The FDA (Devices) publishes a recall like this one as 7 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 7 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The company states that product and process improvements have since reduced the complaint rate.
Baxter Healthcare is recalling Regional Analgesia Infusor Systems with Patient Control due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.
Baxter Healthcare is recalling 3,255,096 Multirate Infusor Devices due to an increase in rupture complaints. The devices are indicated for the intravenous administration of medications.
Baxter Healthcare is recalling 3.2 million Basal/Bolus Infusors due to increased rupture complaints. The devices are used for intravenous medication administration.
Baxter Healthcare is recalling SV Elastomeric Infusion Devices due to an increase in rupture complaints. The devices are used for intravenous medication administration.
Baxter Healthcare is recalling Infusor SV and LV Elastomeric Infusion Devices due to an increase in rupture complaints. The recall aims to ensure no affected product remains in the field.
Baxter Healthcare is recalling Intermate Infusion Pumps due to an increase in rupture complaints. The recall covers 3,255,096 units distributed nationwide and in Puerto Rico.