Pump, Infusion, Elastomeric

B.Braun Accuflo 100ML/H 100ML Elastomeric Infusion Device.

The primary packaging label (inner pouch label) indicates that the package contents are Catalog Item: CT-1000-250, while the secondary packaging label (outer carton label) indicates the contents are CT-1000-100. The actual contents are a CT-1000-100.

B. Braun AccuFlo Elastomeric Infusion Pump 200ML/H 100 ML

Internal testing of two lots of the AccuFlo CT-2000-100 Elastomeric Infusion Pump identified flow rates which are outside the specified infusion time and may result in overly rapid infusion of medications.

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Baxter's elastomeric infusion pumps are non-electronic, ambulatory, disposable devices that deliver continuous medication for periods of 30 minutes up to 7 days

There are reported incidents of leakage on the INFUSOR and FOLFUSOR pumps at the connection of the blue winged cap and the distal male Luer. Investigation of these reports indicates the incidence of leakage has only occurred after pumps are filled, primed, re-capped (using the blue winged Luer cap) and stored for a period of time, typically overnight. In addition, the reported instances of leakage

Brand Name: Infusor SV and LV Elastomeric Infusion Devices.

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.

Brand Name: Multirate Infusor Devices.

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.

Brand Name: Regional Analgesia Infusor System with Patient Control.

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.

Brand Name: Intermate Infusion Pump.

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.

Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device

Due to an increase in complaints for leaks at the distal male Luer and Luer cap. Baxter implemented enhancements to the blue winged cap to improve the seal between the cap and the Luer.