The Recall Desk

FDA (Drugs) recall action 87907

Fresenius Medical Care Holdings, Inc. recalled 8 products on 2021-06-16

The FDA (Drugs) publishes a recall like this one as 8 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 8 pages.

Products
8
Announced
2021-06-16
Critical
0
Units
1,127

Why these products were recalled

Temperature Abuse: Product exposed to temperature outside specified limits.

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.

1–8 of 8

  • ModerateFDA (Drugs)··2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recall for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose (5000 mL bags, 2-pack) due to temperature abuse during storage or transport that may have compromised product integrity.

    Product
    DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack, Rx Only, Fresenius Medical Care NA, Waltham, MA 02451, NDC 49230-0188-50
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (Lot #20PU04030, 4 cases) distributed nationwide because the product was exposed to temperatures outside specified limits, which may affect safety and efficacy.

    Product
    DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (1.5% Dextrose with exchange set) distributed nationwide because the product was exposed to temperatures outside specified limits.

    Product
    DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

    Fresenius Medical Care is recalling 285 cases of DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution.

    Product
    DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Abuse

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution nationwide because the product was exposed to temperatures outside specified limits during distribution, which may compromise sterility or safety.

    Product
    DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-06-16

    Sodium Chloride 0.9% USP 1000 mL Recall for Temperature Abuse

    Fresenius Medical Care is recalling Sodium Chloride 0.9% USP 1000 mL injection (Lot #20NG02095, expiration October 2021) because the product was exposed to temperatures outside specified limits, which may affect its sterility and safety.

    Product
    Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North America, Waltham, MA 02451, NDC 46163-0300-10
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-06-16

    DELFLEX Peritoneal Dialysis Solution Recalled for Temperature Exposure

    Fresenius Medical Care is recalling DELFLEX Peritoneal Dialysis Solution (39 cases nationwide) because the product was exposed to temperatures outside specified limits during storage or distribution.

    Product
    DELFLEX (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE)
    Category
    Distribution
    0 states
  • LowFDA (Drugs)··2021-06-16

    DELFELX Peritoneal Dialysis Solution Recalled Due to Temperature Abuse

    Fresenius Medical Care is recalling 49 cases of DELFELX Peritoneal Dialysis Solution (5000 mL, 4.25% Dextrose) because the product was exposed to temperatures outside specified limits.

    Product
    DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low Calcium, 5000 mL, Fresenius Medical Care, Waltham, MA 02451, NDC 49230-0212-50
    Category
    Distribution
    0 states