ICU Medical Recalls Cardiac Catheterization Kits Due to Leak Risk
ICU Medical is recalling 70 cardiac catheterization kits containing Transpac IV transducers due to a potential leak in the SafeSet Reservoir system.
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 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 70 units of the Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac IV Disposable Transducer (Item No. 46083-03). The recall involves the SafeSet Reservoir and blood sampling kits that contain the Transpac IV transducers.
The recall was initiated because ICU Medical 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 is a blood sampling system assembled directly to the patient monitoring line.
The affected products were distributed nationwide. No specific dates, lot numbers, or additional distribution details are provided in the source text. Consumers and healthcare providers should stop using the affected kits and contact ICU Medical for further instructions.
The recalled product
- Product
- Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable Transducer, Item No. 46083-03 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a cat
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 70
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)
- 3247302
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.
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