Agency classClass IIOur severity:High FDA (Devices)·Z-1588-2015·Announced 2015-05-13

ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk

ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage. The recall affects 250 units distributed in nine US states.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 3/5 (High).

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 with a risk of harm (leakage due to separation) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

ICU Medical, Inc. is recalling 250 units of MicroClave T-Connectors. The affected products are part of the 119" (302 cm) Transfer Set with MicroClave T-Connector, Smallbore Quadfuse Ext Set with 3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037. These devices are intended for the infusion and withdrawal of fluids and are provided sterile.

The recall was initiated because the T-Connectors have potential connection separation issues that could lead to leakage. The affected units are identified by Lot Nos. 2977625, 2992751, and 2995225.

The products were distributed nationwide in the United States, specifically in South Carolina, North Carolina, Minnesota, Connecticut, Kentucky, Maryland, Florida, Virginia, and Tennessee. Healthcare facilities and consumers should stop using the affected devices and contact ICU Medical for further instructions.

The recalled product

Product: 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Administration Sets
Hazard: leakage
connection-separation
Affected units: 250

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 No. 2977625 2992751 2995225

Distribution

Distributed nationwide across the United States.

The notice also names 9 states specifically:

Part of a larger recall action

This product is one of 8 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 8 products in this recall →

Same manufacturer · ICU Medical, Inc.

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Same hazard · leakage