The Recall Desk
HighFDA (Devices)·Z-2621-2014·Announced 2014-10-01

ICU Medical Recalls Stat 2 Flow Controllers Due to High Flow Rate Risk

ICU Medical is recalling 100 units of ConMed 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 flow rate) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

ICU Medical, Inc. is recalling 100 units of the ConMed Stat 2 flow controller, Item No. B9897. The product is an 83-inch (211 cm) primary IV administration set with a rotating luer, provided sterile for the infusion and withdrawal of fluids.

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 unsafe speeds.

The affected units are from Lot # 2801951. Distribution was worldwide, specifically in the United States (nationwide, with specific mentions of Washington and Oregon) and South Africa. Healthcare providers and consumers should stop using these devices and contact the manufacturer for further instructions.

The recalled product

Product
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. 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
100

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 # 2801951

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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