Agency classClass IIOur severity:High FDA (Devices)·Z-2165-2014·Announced 2014-08-13

ICU Medical Recalls Transpac Arterial Monitoring Kits Due to Leak Risk

ICU Medical is recalling 50 units of Transpac arterial monitoring kits because a component connection may crack and cause 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 potential fluid leak in a medical device used for blood withdrawal and fluid 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 50 units of Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21. The affected product is a Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush, and sampling ports, 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 and cause a fluid leak. The specific lot number for the recalled units is 2837897.

The affected units were distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions.

The recalled product

Product: Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Arterial Monitoring Kit
Hazard: fluid-leak
component-crack
Affected units: 50

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. 2837897

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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