ICU Medical Recalls SafeSet Reservoir and Blood Sampling Kits
ICU Medical is recalling specific 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, but the source text does not report any injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 105 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The affected products are identified by the codes 3274948, 3281379, and 3293483. These kits were distributed nationwide.
The recall was initiated because the company identified a potential for leak with these specific devices. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, while the Transpac IV transducer is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor.
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. Users of these products should refer to the official FDA recall notice for specific instructions on how to handle the affected units.
The recalled product
- Product
- CATH LAB KIT w/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 105
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)
- 3274948 3281379 3293483
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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