ICU Medical recalls 6.5" Smallbore Bifuse Ext Sets with visible connector gap. Product numbers and lot numbers listed for affected units.
Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing.
ICU Medical is recalling a specific type of smallbore medical tubing set due to a manufacturing defect that creates a visible gap between the connector's top and bottom housing. This gap could potentially lead to improper connections or leaks during medical procedures.
The defect creates a visible gap between the connector's top and bottom housing. This gap could allow for improper connections or leaks during medical procedures, potentially affecting patient safety.
Healthcare professionals using the recalled smallbore medical tubing sets are most at risk. Patients receiving care with these sets may be affected if the gap causes leaks or improper connections.
Check for product numbers starting with MC330073, MC330255, MC3302R, MC330362, MC330417, MC330476, MC330583, MC330611, MC330615, MC33087, MC33092, MC33119, MC33196, MC3325, MC33290, MC33312, MC33337, MC33343, MC33348, MC33409, MC33424, MC33425, MC33482, MC33492, MC33493, MC33547, MC33563, MC33632, MC33667, MC33670, MC33671, MC33795, MC33917, MC33980, MC33981, SC137, or Z3420, Z3429, Z3523, Z3574. Also check lot numbers listed in the recall notice.
Look for specific product numbers listed in the recall notice to determine if your unit is affected.
The defect is a visible gap between the connector's top and bottom housing due to a manufacturing defect.
Check for product numbers starting with MC330073, MC330255, MC3302R, MC330362, MC330417, MC330476, MC330583, MC330611, MC330615, MC33087, MC33092, MC33119, MC33196, MC3325, MC33290, MC33312, MC33337, MC33343, MC33348, MC33409, MC33424, MC33425, MC33482, MC33492, MC33493, MC33547, MC33563, MC33632, MC33667, MC33670, MC33671, MC33795, MC33917, MC33980, MC33981, SC137, Z3420, Z3429, Z3523, or Z3574. Also check lot numbers listed in the recall notice.
The recall notice does not specify a remedy, so contact ICU Medical directly for guidance.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1721-2022 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1721-2022 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.
