ICU Medical Recalls Left Heart Kits Due to Potential Leak
ICU Medical is recalling 80 units of Left Heart Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
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 criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 80 units of the Left Heart Kit, Item No. AG8052-NS. The product includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling on patients connected to the monitoring line.
The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected Left Heart Kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- LEFT HEART KIT, Item No. AG8052-NS 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 currents that can be input into a comp
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 80
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)
- 3264177
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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