The Recall Desk

FDA (Devices) recall action 85103

Baxter Healthcare Corporation recalled 3 products on 2020-04-15

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
2020-04-15
Critical
0
Units
595

Why these products were recalled

The Coupler size labeling of the outer tray may not match the Couper size labeling of the inner tray in the GEM Microvascular Coupler Device

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

1–3 of 3

  • ModerateFDA (Devices)··2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling 209 GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices - Product Usage: s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Distribution
    36 states
  • ModerateFDA (Devices)··2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices - Product Usage: is intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Distribution
    36 states
  • ModerateFDA (Devices)··2020-04-15

    Baxter Recalls GEM Microvascular Couplers Due to Labeling Mismatch

    Baxter Healthcare is recalling GEM Microvascular Anastomotic Coupler Devices because the size labeling on the outer tray may not match the inner tray.

    Product
    GEM Microvascular Anastomotic Coupler Devices s intended to be used in the anastomosis of veins and arteries normally encountered in microsurgical procedures only in the peripheral vascular system.
    Category
    Distribution
    36 states