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[Recalled] STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal

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

ProductSTAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Brand / manufacturerICU Medical, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-2620-2014
Country of noticeUnited States
Risk levelClass I
Hazard typerecall
Notice date19 August 2014

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended.

This Class I 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

Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).

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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