ICU Medical recalls 6" small bore medical tubing sets with visible gap between connector housing that may cause leaks during use. Affected units have specific product numbers listed in the recall notice.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
ICU Medical is recalling small bore medical tubing sets that have a visible gap between the connector's top and bottom housing. This defect could allow fluid leaks during medical procedures, potentially causing complications for patients.
The manufacturing defect creates a visible gap between the connector's top and bottom housing. This gap could allow fluid to leak during medical procedures, potentially causing complications for patients.
Healthcare professionals using these medical tubing sets for patient care. Patients receiving treatment with these sets may be at risk of fluid leaks.
Check for product numbers starting with IR-1SF, IR-1S, P039, MC33769, K7059-001, or 011-MC100G in the recall list. These units were sold with specific lot numbers and UDI codes.
Look for product numbers listed in the recall notice, such as IR-1SF 5727531 or IR-1S 5728008.
The tubing sets have a visible gap between the connector's top and bottom housing due to a manufacturing defect.
Check for product numbers starting with IR-1SF, IR-1S, P039, MC33769, K7059-001, or 011-MC100G as listed in the recall notice.
The recall notice does not specify a remedy, so contact ICU Medical directly for further 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-1724-2022 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1724-2022 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.
