ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
ICU Medical is recalling 220 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 hazard where no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 220 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product is the Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07. The Transpac Disposable Straight Pressure Transducer (DSPT) 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.
The recall was initiated because ICU Medical identified a potential for leak with these specific kits. The affected units were distributed nationwide. The source text does not specify any reported illnesses, injuries, or deaths associated with this defect.
Healthcare facilities and consumers should stop using the affected kits immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. 46104-07 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 el
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 220
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)
- 3226840 3247322
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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