The Recall Desk
HighFDA (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.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device defect that poses a risk of harm (excessive fluid delivery) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

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
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 →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · excessive flow rate

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