ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
ICU Medical is recalling 140 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 for leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 140 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The affected products are identified by the item number 46092-34 and are distributed nationwide.
The recall was initiated because the company identified a potential for leak with these specific kits. 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.
Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 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
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 140
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)
- 3235552 3256929
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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