Agency classClass IIOur severity:High FDA (Devices)·Z-2809-2016·Announced 2016-09-21

ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk

ICU Medical is recalling specific Transpac IV Monitoring Kits because of 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 is classified as FDA Class II and involves a medical device with a potential leak hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.

Plain-English summary

ICU Medical, Inc. is recalling 4,180 units of Transpac IV Monitoring Kits, Item No. 42646-06. These kits include 2 SafeSet Reservoirs, 2 Blood Sampling Ports, 84-inch tubing, a disposable transducer, and a 3 mL squeeze flush. The affected units 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 Transpac Disposable Straight Pressure Transducer 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.

Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions. The specific lot codes associated with this recall are 3279178, 3261715, 3226396, and 3251023.

The recalled product

Product: Transpac IV Monitoring Kit with 2 SafeSet Reservoir and 2 Blood Sampling Ports, 84" Tubing, Disposable Transducer, 3 mL Squeeze Flush, Macrodrip (Pole Mount), Item No. 42646-06 Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — IV Monitoring / Pressure Transducer
Hazard: leak
Affected units: 4,180

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)

3279178 3261715 3226396 3251023

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