Agency classClass IIOur severity:High FDA (Devices)·Z-2827-2016·Announced 2016-09-21

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

ICU Medical is recalling 150 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.

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 potential leak hazard where injury has not yet been reported, fitting the criteria for a risk-of-harm product without confirmed adverse events.

Plain-English summary

ICU Medical, Inc. is recalling 150 units of Transpac IV Trifurcated Monitoring Kits with SafeSet Reservoir, Port, and 0.3 ml Squeeze Flush Devices, Item No. 46110-84. The affected products are identified by lot numbers 3264164 and 3178497. These kits were distributed nationwide in the United States.

The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.

Healthcare facilities and consumers who have these specific products should stop using them and contact ICU Medical, Inc. for further instructions on how to return or dispose of the affected units.

The recalled product

Product: Transpac IV Trifurcated Monitoring Kit with SafeSet Reservoir, Port and 03 ml Squeeze Flush Devices, Item No. 46110-84 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Pressure Monitoring
Hazard: leak
Affected units: 150

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 (2)

lot number 3264164
3178497

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 24 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 24 products in this recall →

Same manufacturer · ICU Medical, Inc.

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