The Recall Desk

FDA (Devices) recall action 68585

Fresenius Medical Care Holdings, Inc. recalled 6 products on 2014-09-24

The FDA (Devices) publishes a recall like this one as 6 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 6 pages.

Products
6
Announced
2014-09-24
Critical
0
Units
55

Why these products were recalled

Products were held at improper storage temperature

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

1–6 of 6

  • ModerateFDA (Devices)··2014-09-24

    Fresenius Recalls BD Vacutainer EDTA Tubes Due to Improper Storage

    Fresenius Medical Care is recalling 26 boxes of BD Vacutainer EDTA tubes held at improper storage temperatures. The affected lots were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer EDTA Tubes (LAVENDER TOP TUBE 2.0ML) Part Number: BD 367841 Part Number: FMC 87-7841-7 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-09-24

    Fresenius Recalls BD Vacutainer SST Tubes for Improper Storage Temperature

    Fresenius Medical Care is recalling 9 boxes of BD Vacutainer SST Tubes held at improper storage temperatures. The tubes were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer SST Tubes (RED/GREY TOP SST TUBE 3.5ML) Part Number: BD 367981 Part Number: 87-7981-5 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. serum determination in…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-09-24

    Fresenius Recalls BD Vacutainer Trace Element Tubes Due to Storage Issues

    Fresenius Medical Care is recalling specific BD Vacutainer Trace Element Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Trace Element Tubes (ROYAL BLUE TOP TUBE 6.0ML) Part Number: 363083 Part Number: FMC 87-8380-1 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Trace elements…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-09-24

    Fresenius Recalls BD Vacutainer PST Tubes Due to Improper Storage Temperature

    Fresenius Medical Care is recalling BD Vacutainer PST Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer PST Tubes (GOLD TOP PST TUBE 3ml) Part Number: BD 367960 FMC part Number: 87-4544-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. The concentrate is formulated to…
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-09-24

    Fresenius Recalls BD Vacutainer Serum Tubes Due to Improper Storage Temperature

    Fresenius Medical Care is recalling 3 boxes of BD Vacutainer Serum Tubes because they were held at improper storage temperatures. The affected units were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Serum Tubes (RED TOP PLAIN TUBE 6.0 ML)Part Number: BD 367815 FMC Part Number: 87-7815-4 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use.
    Category
    Distribution
    3 states
  • ModerateFDA (Devices)··2014-09-24

    Fresenius Medical Care Recalls BD Vacutainer Citrate Tubes Due to Storage Issues

    Fresenius Medical Care is recalling BD Vacutainer Citrate Tubes because they were held at improper storage temperatures. The affected tubes were distributed in Louisiana, Oklahoma, and Texas.

    Product
    BD Vacutainer Citrate Tubes (LIGHT BLUE TOP TUBE 2.7ML)Part number: BD 363083 Part Number: FMC 87-3083-8 Single use tube used to collect, separate, transport or process blood specimens for laboratory determinations for in vitro diagnostic use. Coagulation studies.
    Category
    Distribution
    3 states