The Recall Desk

FDA (Devices) recall action 82975

Maquet Cardiovascular Us Sales, Llc recalled 2 products on 2019-06-19

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
2019-06-19
Critical
0
Units
44

Why these products were recalled

Possibility that inlet pump hose of the Washer Disinfector Getinge 86-Series (S-8666, S-8668) might collapse during use result in low water pressure within the circulation system and, in the worst case scenario, can result in the contents of the Washer Disinfector not being cleaned properly after finished process.

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)··2019-06-19

    Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse

    Maquet Cardiovascular is recalling 40 Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.

    Product
    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86682003 Product Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets, and…
    Category
    Distribution
    8 states
  • HighFDA (Devices)··2019-06-19

    Getinge 86-Series Medical Washer-Disinfector Recalled for Potential Hose Collapse

    Maquet Cardiovascular is recalling four Getinge 86-Series Medical Washer-Disinfector units because the inlet pump hose may collapse, potentially preventing proper cleaning of medical instruments.

    Product
    Getinge 86-Series-Medical Washer-Disinfector Part Number: S-86662003 Product Usage: Usage: The Getinge 86 Series Medical Washer-Disinfector is designed for use in healthcare facilities and laboratories where reusable items such as instruments, utensils, anesthesia sets…
    Category
    Distribution
    8 states