ICU Medical recalls specific pressure infusion sets with a visible gap between connector housing that could cause leaks. Affected units have unique product numbers and UDI codes 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 certain pressure infusion sets that have a visible gap between the connector's top and bottom housing. This defect could allow fluid leaks, potentially causing complications during medical use.
The manufacturing defect creates a visible gap between the connector's top and bottom housing. This gap could allow fluid to leak, which might cause complications during medical procedures requiring precise fluid delivery.
Patients using these specific pressure infusion sets for medical treatment are affected. Healthcare providers who use the recalled models are most at risk due to potential fluid leaks.
Check for product numbers starting with A1099, A1129, A1132, A1152, MC330113, MC330246, MC330247, MC33056, MC330605, MC33122, MC33213, MC33326, MC33600, MC33729, MC33786, or Z3419/Z3678. The UDI codes and lot numbers listed in the recall notice are unique identifiers for affected units.
Verify your product's specific product number and UDI codes against the list provided in the recall notice.
The defect is a visible gap between the connector's top and bottom housing due to a manufacturing defect.
Check if your product number starts with A1099, A1129, A1132, A1152, MC330113, MC330246, MC330247, MC33056, MC330605, MC33122, MC33213, MC33326, MC33600, MC33729, MC33786, or Z3419/Z3678, and matches the listed UDI codes and lot numbers.
No, the recall does not require immediate discontinuation. Affected users should check their product details and follow the provided steps.
We’ve drafted a message you can send ICU Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-1720-2022 — ICU Medical ICU Medical Hello, I own a ICU Medical that is covered by recall Z-1720-2022 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.
