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 involves a medical device with a potential leak hazard where no 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 SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The recall involves the Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641. 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. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
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 source text does not specify the number of units affected, the specific dates of distribution, or whether any injuries or illnesses have been reported.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions. The recall is classified as Class II by the U.S. Food and Drug Administration.
The recalled product
- Product
- Expression MR IBP DPT Kit, I/N, Box 20, Item No. 989803194641 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 th
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 1,000
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)
- 3258299
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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