ICU Medical Recalls Transpac Transducer Kits Due to Leak Risk
ICU Medical is recalling 60 units of Transpac IV transducer kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
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 rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 60 units of the Transpac Disposable Straight Pressure Transducer (DSPT) kits, specifically Item No. 46097-64. These medical devices are extravascular pressure transducers that interface between a catheter and a pressure monitor to convert pressure changes into electrical currents. The kits include the SafeSet Reservoir system, which is a blood sampling system assembled directly to the patient monitoring line for patients requiring periodic blood sampling.
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 affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected transducer kits immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or replace the devices.
The recalled product
- Product
- TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 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 curre
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 60
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)
- 3231400
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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