Agency classClass IIOur severity:High FDA (Devices)·Z-2157-2014·Announced 2014-08-13

ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk

ICU Medical is recalling 20 units of Transpac IV Trifurcated Monitoring Kits because a component connection may crack, causing a fluid leak.

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 the hazard involves a fluid leak in a medical device used for monitoring and infusion, which poses a risk of harm even though no specific injuries are reported in the source text.

Plain-English summary

ICU Medical, Inc. is recalling 20 units of Transpac IV Trifurcated Monitoring Kits, Item No. 46112-52. The affected product is identified by Lot No. 2886730. These kits are intended for measuring and monitoring fluid pressure, fluid infusion, and blood withdrawal.

The recall was initiated because ICU Medical became aware of an issue with a component where the connection on the arterial monitoring kit may crack. This defect can cause a fluid leak. The agency classified this recall as Class II.

The affected units were distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers who have this specific product should stop using it and contact ICU Medical for instructions on return or replacement.

The recalled product

Product: Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Monitoring Kit
Hazard: fluid-leak
component-crack
Affected units: 20

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. 2886730

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 9 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 9 products in this recall →

Same manufacturer · ICU Medical, Inc.

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