ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
ICU Medical is recalling 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 is classified as FDA Class II. The hazard is a potential leak in a medical device used for blood sampling, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The recall involves 750 units of the CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76. The affected products were 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. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the leak. The recall is classified as Class II by the FDA.
The recalled product
- Product
- CATH LAB KIT w/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting chan
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 750
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)
- 3273544 3274949 3284432 3288502 3293484 3296873
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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