The Recall Desk
HighFDA (Devices)·Z-0572-2017·Announced 2016-11-23

ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak

ICU Medical is recalling 20 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 leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ICU Medical, Inc. is recalling 20 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product involved is the 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac IV, Item No. 46300-14NS. These devices are extravascular pressure transducers used to interface between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.

The recall was initiated because the company identified a potential for leak with these specific kits. The affected units were distributed nationwide.

Healthcare facilities and consumers should stop using the affected SafeSet Reservoir and blood sampling kits immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or dispose of the recalled products.

The recalled product

Product
4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS 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 electrical
Manufacturer
ICU Medical, Inc.
Category
Medical Device — Pressure Transducer
Hazard
Affected units
20

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)

  • 3288582

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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