The Recall Desk
HighFDA (Devices)·Z-0571-2017·Announced 2016-11-23

ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits

ICU Medical is recalling 40 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.

What this means for you

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 for leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 40 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The affected products are identified by code 3275023 and were distributed nationwide.

The recall was initiated because the company identified a potential for leak with these specific kits. The Transpac IV transducer is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.

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

The recalled product

Product
Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac¿ IV, Waste Bag System and 10 cc Control Syringe, Item No. 46300-11NS The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pre
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Pressure Transducer
Hazard
Affected units
40

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)

  • 3275023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 162 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 162 products in this recall →

Related recalls

Same manufacturer · ICU Medical, Inc.

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Same hazard · leak

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