ICU Medical recalls 131" 10 Drop Primary Sets with incorrect drop cannulas that may cause under-delivery of critical medication. Affected units include specific model and lot numbers. Consumers should contact for remedy.
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 131-inch IV sets that may have a 15 drops/mL cannula instead of the required 10 drops/mL. This could lead to under-delivery of critical medications, risking serious health consequences.
The IV sets may contain a 15 drops/mL drop cannula instead of the required 10 drops/mL. This error causes under-delivery of medication, potentially leading to serious health issues if critical drugs are not delivered in sufficient amounts.
Healthcare professionals and patients using ICU Medical's 131" 10 Drop Primary Sets with specific model and lot numbers are affected. Those administering critical medications are at highest risk.
Check for model number Z3806, 131" (333 cm) 10 Drop Primary Set with 2 MicroClaves, 4-way stopcocks, and check valve. Affected units have lot number 4169642.
Reach out to ICU Medical for specific remedy instructions and to confirm if your unit is affected.
The recalled model is Z3806, 131" (333 cm) 10 Drop Primary Set with 2 MicroClaves, 4-way stopcocks, and check valve.
The incorrect drop cannula may cause under-delivery of medication, potentially leading to serious health consequences if critical drugs are not delivered in sufficient amounts.
Contact ICU Medical directly to determine if your unit is affected and follow their instructions.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1920-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1920-2020 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.
