ICU Medical recalls 126" 10 Drop Primary Sets with potential 15 drops/mL drop cannula causing inaccurate medication delivery. Affected units may lead to under-delivery of critical medication.
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.
ICU Medical is recalling 126-inch 10 drop primary IV sets that might have a 15 drops/mL drop cannula instead of the required 10 drops/mL. This could cause under-delivery of critical medications, potentially leading to serious health issues.
The IV set may contain a 15 drops/mL drop cannula instead of the required 10 drops/mL. This error causes inaccurate medication delivery, potentially leading to under-delivery of critical drugs. Under-delivery could result in serious health consequences for patients.
Healthcare professionals using the recalled IV sets for patient care are most at risk. Patients receiving medication through these sets could experience under-delivery of critical treatments.
Check for the model number REF: Z3239 on the product label. The affected units have lot number 4169647 and were sold with the specific 126-inch 10 drop primary set configuration.
Look for the model number REF: Z3239 and lot number 4169647 on the IV set label.
The recall is due to a potential 15 drops/mL drop cannula in the IV set instead of the required 10 drops/mL, which could cause under-delivery of critical medications.
Check the product label for model number REF: Z3239 and lot number 4169647. If you have the affected units, contact ICU Medical for guidance.
The recall record does not specify a remedy or fix for the affected units.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1919-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1919-2020 from ICU Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
