Agency classClass IIOur severity:Severe FDA (Devices)·Z-2159-2014·Announced 2014-08-13

ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk

ICU Medical is recalling specific arterial 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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classifies this as a Class II recall involving a structural defect in a medical device that can cause fluid leaks, which aligns with the rubric criteria for Severe severity.

Plain-English summary

ICU Medical, Inc. is recalling 1,560 units of the Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount (Item No. 011-46104-42). The affected lots are 2841944, 2841945, 2859326, 2865873, and 2869445. 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 classifies this as a Class II recall.

The affected products were distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers should stop using these specific kits and contact ICU Medical for instructions on how to return or replace the devices.

The recalled product

Product: Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Arterial Monitoring Kit
Hazard: fluid-leak
component-crack
Affected units: 1,560

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 (5)

Lot No. 2841944
2841945
2859326
2865873
2869445

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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