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[Recalled] ICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188 — Port weld of drug transfer device may separate or break

recall fda device united-states

A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.

Recall details

ProductICU Medical Oncology Kit w/2 ChemoLock", 13mm Closed Vial Spike w/ChemoLock" Port, ChemoLock" Bag Spike, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL4188
Brand / manufacturerICU Medical, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0362-2026
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date08 September 2025
EAN / barcode14369087

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Port weld of drug transfer device may separate or break during use and potentially result in a leak.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from ICU Medical, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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