Agency classClass IOur severity:Severe FDA (Devices)·Z-2619-2014·Announced 2014-10-01

ICU Medical Recalls STAT 2 Flow Controllers Due to High Flow Rate

ICU Medical is recalling STAT 2 Flow Controllers because they may deliver a significantly higher flow rate than intended.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "ICU is recalling the ConMed Stat 2 flow controller because it may deliver a significantly higher flow rate than was intended."

Plain-English summary

ICU Medical, Inc. is recalling the ConMed STAT 2 Flow Controller, Item No. 011-C9801. The affected product is an IV administration set intended for the infusion and withdrawal of fluids, provided sterile. The specific lot number is 2768416, and 3,750 units were distributed.

The recall was initiated because the flow controller may deliver a significantly higher flow rate than was intended. This defect could result in the administration of fluids at a rate that exceeds the prescribed or intended volume.

The affected units were distributed worldwide, specifically in the United States (nationwide) in the states of Washington and Oregon, and in South Africa. Consumers and healthcare providers should stop using the affected devices and contact ICU Medical for instructions on return or replacement.

The recalled product

Product: STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: excessive-flow-rate
Affected units: 3,750

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

Lot # 2768416

Distribution

Distributed nationwide across the United States.

The notice also names 2 states specifically:

Part of a larger recall action

This product is one of 4 recalled by ICU Medical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

Same manufacturer · ICU Medical, Inc.

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