ICU Medical recalls 10-drop IV sets with potential 15-drop cannula causing under-delivery of critical medication. Affected units include specific lot numbers and model REF: Z2812. Stop using immediately to prevent serious health risks.
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 10-drop IV sets that may have a 15-drop cannula instead of the required 10-drop cannula. This could cause under-delivery of critical medication, potentially leading to serious health issues. Affected units have specific lot numbers and model identifiers.
The IV set may contain a 15-drop cannula instead of the required 10-drop cannula. This causes the infusion to deliver less medication than intended, which could lead to under-delivery of critical drugs. Under-delivery might result in serious health consequences if the medication is life-saving.
Healthcare professionals and patients using ICU Medical's 10-drop IV sets with the model REF: Z2812 are affected. Those with the specific lot numbers 4168876, 4168877, 4169640, or 4169641 are most at risk.
Check for the model REF: Z2812 on the product label. Affected units have lot numbers 4168876, 4168877, 4169640, or 4169641. The product includes a 121" length with 5 MicroClaves and 2 external connections.
Discard the affected IV set to prevent under-delivery of critical medication.
The model number is REF: Z2812.
Lot numbers 4168876, 4168877, 4169640, and 4169641 are affected.
The IV set may contain a 15-drop cannula instead of the required 10-drop cannula, causing under-delivery of critical medication.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1917-2020 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1917-2020 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.
