The Recall Desk

FDA (Devices) recall action 62108

Fresenius Medical Care Holdings, Inc. recalled 2 products on 2012-07-04

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
2012-07-04
Critical
0
Units
—

Why these products were recalled

Risk of Alkalosis with acetate containing dialysis acid concentrates

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • HighFDA (Devices)··2012-07-04

    Fresenius GranuFlo Acid Concentrate Recalled for Risk of Alkalosis

    Fresenius Medical Care is recalling GranuFlo Acid Concentrate due to a risk of alkalosis in patients undergoing hemodialysis.

    Product
    Fresenius GranuFlo (powder) Acid Concentrate Product Codes: OFD1201-3B, OFD1251-3B, OFD2123-3B, OFD2201-3B, OFD2220-3B, OFD2223-3B,OFD2225-3B, OFD2231-3B, OFD2251-3B, OFD2301-3B, OFD2323-3B, OFD2325-3B, OFD3201-3B, OFD3231-3B, OFD3251-3B, OFD3301-3B. For the treatment of acu
    Category
    Distribution
    0 states
  • HighFDA (Devices)··2012-07-04

    Fresenius NaturaLyte Liquid Acid Concentrate Recalled for Alkalosis Risk

    Fresenius Medical Care is recalling NaturaLyte Liquid Acid Concentrate due to a risk of alkalosis. The product is used for hemodialysis.

    Product
    Fresenius NaturaLyte Liquid Acid Concentrate Product Codes: 08-0231-4, 08-1001-0, 08-1201-8, 08-1231-3, 08-1251-1, 08-1301-4, 08-2201-5, 08-2231-2, 08-2251-0, 08-2301-3,08-2351-8,08-3201-4,08-3231-1,08-3251-9,08-3301-2,08-4123-1, 08-4223-7, 08-4225-1' 08-4230-2, 08-4231-0, 08-
    Category
    Distribution
    0 states