ICU Medical Recalls Cath Lab Kits Due to Potential Leak
ICU Medical is recalling 360 units of Cath Lab Kits for Genesis Health Care due to a potential leak in the SafeSet Reservoir and blood sampling kits.
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 specific injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 360 units of the Cath Lab Kit for Genesis Health Care, Item No. 46089-74. The affected products include the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling in 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 products were distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 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
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 360
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)
- 3265552 3288453
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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