Agency classClass IIOur severity:High FDA (Devices)·Z-2819-2016·Announced 2016-09-21

ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

ICU Medical is recalling 125 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for 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 involves a medical device with a potential leak hazard where no injuries or illnesses have been reported, fitting the rubric criteria for risk-of-harm products without reported injury.

Plain-English summary

ICU Medical, Inc. is recalling 125 units of SafeSet Reservoir and blood sampling kits, Item No. 46083-42, which contain Transpac IV transducers. The recall is being conducted because the company identified a potential for leak with these specific kits. The affected products were distributed nationwide in the United States.

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. The Transpac Disposable Straight Pressure Transducer (DSPT) interfaces between a catheter and pressure monitor by converting pressure changes into electrical currents. The recall covers specific lot codes: 3281099, 3253971, and 3265533.

Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical, Inc. for further instructions or a return. The source text does not report any specific injuries or illnesses associated with this recall.

The recalled product

Product: SafeSet Kit with 30 mL Flush Device, Item No. 46083-42 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressure into…
Manufacturer: ICU Medical, Inc.
Category: Medical Device — Blood Sampling / Pressure Transducer
Hazard: leak
Affected units: 125

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)

3281099 3253971 3265533

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