FDA (Devices) recall action 85053
The FDA (Devices) publishes a recall like this one as 10 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 10 pages.
There is a potential that IV administration sets contain a 15 drops/mL drop cannula instead of a 10 drops/mL drop cannula within the drip chamber. An infusion set with an incorrect drop cannula could result in inaccurate delivery of the intended infusion volume (under-delivery). This could result in under-delivery of critical medication which may lead to serious adverse health consequences.
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.
ICU Medical is recalling 650 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
ICU Medical is recalling 350 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.
ICU Medical is recalling 675 IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking under-delivery of critical medication.
ICU Medical is recalling specific IV administration sets that may contain a 15 drops/mL cannula instead of a 10 drops/mL cannula, risking inaccurate medication delivery.
ICU Medical is recalling 50 units of 10 Drop Primary IV Sets because they may contain 15 drops/mL cannulas, risking under-delivery of critical medications.
ICU Medical is recalling veterinary IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of medication.
ICU Medical is recalling IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
ICU Medical is recalling 25 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
ICU Medical is recalling 14,000 IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medication.
ICU Medical is recalling 275 units of IV administration sets that may contain a 15 drops/mL cannula instead of 10 drops/mL, risking under-delivery of critical medications.