Agency classClass IIOur severity:High FDA (Devices)·Z-1590-2015·Announced 2015-05-13

ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation

ICU Medical is recalling 1,500 MicroClave T-Connectors because potential connection separation issues could lead to leakage.

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 connection separation) where no specific injuries or illnesses have been reported in the source text, fitting the High severity criteria for risk-of-harm products.

Plain-English summary

ICU Medical, Inc. is recalling 1,500 units of MicroClave T-Connectors. The affected products are part of the 104" (264 cm) Transfer Set, Item No. B33065, which includes components such as check valves, smallbore trifuse extensions, anti-siphon valves, and clamps. These IV administration sets are intended for the infusion and withdrawal of fluids and are provided sterile.

The recall is being issued because the MicroClave T-Connectors have potential connection separation issues that could lead to leakage. The affected lots are 2992752, 2997916, 3004237, 3019517, and 3026353.

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 check their inventory for these specific lot numbers and stop using the affected devices if found.

The recalled product

Product: 104" (264 cm) Transfer Set w/MicroClave T-Connector, Check Valve, Smallbore Trifuse Ext w/2 MicroClave, Anti-Siphon Valve, 3 Clamps (White, Red, Blue), Rotating Luer, Non-DHEP Tubing, Item No. B33065 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: 1,500

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. 2992752 2997916 3004237 3019517 3026353

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