Agency classClass IIOur severity:High FDA (Devices)·Z-1593-2015·Announced 2015-05-13

ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

ICU Medical is recalling 5,100 units of 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 is classified as FDA Class II and involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.

Plain-English summary

ICU Medical, Inc. is recalling 5,100 units of 127" (323cm) Transfer Sets with MicroClave T-Connectors, Item No. B33351. The affected lots are 2997914, 2997918, 2998570, 3001230, and 3001231. These IV administration sets are intended for the infusion and withdrawal of fluids and are provided sterile.

The recall is being conducted because the MicroClave T-Connectors have potential connection separation issues that could lead to leakage. The agency has classified this as a Class II recall.

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

The recalled product

Product: 127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 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: leakage
connection-separation
Affected units: 5,100

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 No. 2997914 2997918 2998570 3001230 3001231

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