The Recall Desk

FDA (Devices) recall action 70681

Maquet Cardiovascular Us Sales, Llc recalled 2 products on 2015-06-03

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
2015-06-03
Critical
0
Units
10,199

Why these products were recalled

A potential issue was detected that could result in blood leakage from the gas outlet port in all lots of Quadrox-iD Adult Diffusion Membrane Oxygenator with Bioline and Softline Coatings, Custom Tubing Packs and Diffusion Membrane HLS Set Advanced and HIT Set Advanced Models.

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.

1–2 of 2

  • HighFDA (Devices)··2015-06-03

    Maquet Quadrox-iD Adult Diffusion Membrane Oxygenator Recalled for Blood Leakage Risk

    Maquet Cardiovascular is recalling Quadrox-iD Adult Diffusion Membrane Oxygenators due to a potential issue that could result in blood leakage from the gas outlet port.

    Product
    Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in cardiac surgery. Within the specified flow rate range, the device oxygenates
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2015-06-03

    Maquet Cardiovascular Recalls HLS/HIT Set Advanced Due to Blood Leakage Risk

    Maquet Cardiovascular is recalling HLS/HIT Set Advanced consoles because a potential issue could cause blood to leak from the gas outlet port.

    Product
    HLS/HIT Set Advanced with Bioline and/or Softline Coating Console Product Usage: HLS/HIT Set Advanced: The CARDIO HELP System in configuration with the HLS/HIT Set Advanced is intended to be used within the hospital environment and outside the hospital environment (for peri
    Category
    Distribution
    0 states