Agency classClass IIOur severity:High FDA (Devices)·Z-2806-2016·Announced 2016-09-21

ICU Medical Recalls Transpac IV Trifurcated Kits Due to Leak Risk

ICU Medical is recalling 250 units of Transpac IV Trifurcated 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 no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 250 units of the Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, Item No. 42500-04. The affected products are identified by lot number 3264103 and were distributed nationwide in the United States.

The recall was initiated because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The product is an extravascular pressure transducer system used to interface between a catheter and a pressure monitor, with a reservoir system for periodic blood sampling.

Healthcare facilities and consumers should stop using the affected units and contact ICU Medical, Inc. for further instructions on the recall.

The recalled product

Product: Transpac IV Trifurcated Kit With Safeset Reservoir And 2 Blood Sampling Ports, 84 inch Tubing, 3 3 ml Intraflo Flushes, 3 Disposable Transducers, Macrodrip, Item No. 42500-04 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Therapy / Monitoring
Hazard: leak
Affected units: 250

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 number 3264103

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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Same hazard · leak