The Recall Desk

FDA (Devices) recall action 73528

ICU Medical, Inc. recalled 6 products on 2016-04-20

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
2016-04-20
Critical
0
Units
196

Why these products were recalled

ICU Medical Inc. has received a report of compounded volumes not meeting the accuracy specification by the Diana Compounding System when mixing volumes under 5ml.

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)··2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues

    ICU Medical is recalling 57 Diana Automated Compounding Systems because they may not accurately mix volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana Onco Plus 1.2, Item No. ASN222, ASN222-GST, ASN222-R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems Due to Volume Accuracy Issues

    ICU Medical is recalling 47 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Final Assembly, Diana Onco Plus, Item No. CH5000, CH5000R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Distribution
    22 states
  • ModerateFDA (Devices)··2016-04-20

    ICU Medical Recalls Diana Automated Compounding Systems for Accuracy Issues

    ICU Medical is recalling 36 Diana Automated Compounding Systems because they may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana Onco Plus, Item No. ASN220 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 4 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.

    Product
    Diana Automated Compounding System, Diana Onco 3xx, Item No. ASN303 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 3 units of the Diana Automated Compounding System because compounded volumes under 5ml may not meet accuracy specifications.

    Product
    Diana Automated Compounding System, Diana Onco Plus 1.3, Item No. ASN223 The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Distribution
    22 states
  • HighFDA (Devices)··2016-04-20

    ICU Medical Recalls Diana Automated Compounding System Due to Accuracy Issues

    ICU Medical is recalling 49 units of the Diana Automated Compounding System because it may not meet accuracy specifications when mixing volumes under 5ml.

    Product
    Diana Automated Compounding System, Diana V1.3, Item No. CH5300, CH5300R The Diana is an automated compounding device for the accurate, safe and efficient preparation of solutions by a pharmacist prior to delivery for infusion into patient.
    Category
    Distribution
    22 states