ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 30 units of Transpac pressure transducers and SafeSet reservoirs due to a potential 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 without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 30 units of the Transpac Disposable Straight Pressure Transducer (DSPT) and associated SafeSet Reservoir blood sampling kits. The specific product is the TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08.
The recall was initiated because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The Transpac DSPT is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir is a blood sampling system used on patients requiring periodic blood sampling.
The affected units were distributed nationwide. No specific dates, lot numbers, or reported injuries are provided in the source text.
The recalled product
- Product
- TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 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 el
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 30
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)
- 3265549
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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