The Recall Desk

FDA (Devices) recall action 85057

Applied Medical Resources Corp recalled 3 products on 2020-05-13

The FDA (Devices) publishes a recall like this one as 3 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 3 pages.

Products
3
Announced
2020-05-13
Critical
1
Units
86,397

Why these products were recalled

The firm has received reports of tip separation during usage of the catheters, which may expose patients to unintended dislodgement of the tip from the body of the catheter.

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.

1–3 of 3

  • HighFDA (Devices)··2020-05-13

    Applied Medical Recalls Python Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Python Embolectomy Catheters because the tips may separate during use, posing a risk of unintended dislodgement in patients.

    Product
    Python Embolectomy Catheters, Sterile EO, CE, Ref numbers/UDI: A4E01/(01)00607915113407; A4E02/(01)00607915113414; A4E03/(01)00607915113421; A4E04/(01)00607915113438; A4E05/(01)00607915113445; A4E06/(01)00607915113452; A4E08/(01)00607915113476; A4E09/(01)00607915113483
    Category
    Distribution
    0 states
  • SevereFDA (Devices)··2020-05-13

    Applied Medical Dual Lumen Graft Cleaning Catheter Recall for Tip Separation

    Applied Medical Resources Corp is recalling 28,799 Dual Lumen Graft Cleaning Catheters due to reports of tip separation during use, which may expose patients to unintended dislodgement.

    Product
    Applied Medical Dual Lumen Graft Cleaning Catheter & 1cc SYRINGE Nonpyrogenic, REF: A4GW6, 5F X 60cm, 9mm, Sterile EO, CE, UDI: (01)00607915111175
    Category
    Distribution
    0 states
  • CriticalFDA (Devices)··2020-05-13

    Applied Medical Recalls Bard Embolectomy Catheters Due to Tip Separation

    Applied Medical Resources Corp is recalling Bard Embolectomy Catheters because the tips may separate during use, posing a risk of dislodgement in patients.

    Product
    Bard Embolectomy Catheter & 1 ml SYRINGE, REF numbers/UDI: CE0340DR/(01)H699CE0340DR10R; CE0380DR/(01)H699CE0380DR10V; CE0440DR/(01)H699CE0440DR10S; CE0480DR/(01)H699CE0480DR10W; CE0540DR/(01)H699CE0540DR10T; CE0580DR/(01)H699CE0580DR10X; CE0680DR/(01)H699CE0680DR10
    Category
    Distribution
    0 states