The Recall Desk

FDA (Devices) recall action 65364

Baxter Healthcare Corp. recalled 2 products on 2013-07-03

The FDA (Devices) publishes a recall like this one as 2 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 2 pages.

Products
2
Announced
2013-07-03
Critical
0
Units
1,202,460

Why these products were recalled

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.

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.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2013-07-03

    Baxter Recalls Infusor SV Elastomeric Infusion Devices Due to Leak Complaints

    Baxter Healthcare is recalling 601,230 Infusor SV Elastomeric Infusion Devices due to increased complaints of leaks at the distal male Luer and Luer cap.

    Product
    Brand Name: Coiled Tube Infusors (Portable Elastomeric Infusion Systems). Baxter's Infusor SV Elastomeric Infusion Device Device Listing: D020871 Baxter's lnfusors SV Elastomeric Infusion Device is a single-use, disposable elastomeric infusion pump indicated tor patients
    Category
    Distribution
    1 state
  • ModerateFDA (Devices)··2013-07-03

    Baxter Recalls Infusor Devices Due to Potential Leaks at Luer Connections

    Baxter Healthcare is recalling specific Infusor devices because of increased complaints about leaks at the distal male Luer and Luer cap.

    Product
    Brand Name: Multiday lnfusor, Seven Day lnfusor and the Basal/Bolus lnfusor: Single day Infusor 2 ml/h, Single Day INFUSOR 2 ml/h System, Half Day INFUSOR SV 5 ml/h System, Two Day INFUSOR 2 ml/h System, Two day Infusor 2 ml/h, Multiday Infusor 0.5 ml/h, Multiday
    Category
    Distribution
    1 state