ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 180 units of Transpac IV Disposable Transducers due to a potential leak in the SafeSet Reservoir and blood sampling kits.
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 injury has not yet been reported, fitting the criteria for a risk-of-harm product without reported illness.
Plain-English summary
ICU Medical, Inc. is recalling 180 units of Transpac IV Disposable Transducers with Stopcocks (Item No. 46112-30NS). The recall covers specific SafeSet Reservoir and blood sampling kits that contain these transducers.
The recall was initiated because the company identified a potential for leak with the affected kits. The Transpac Disposable Straight Pressure Transducer is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is used for periodic blood sampling on patients.
The affected products were distributed nationwide. Consumers and healthcare providers should stop using the affected units and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- Transpac¿ IV Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. 46112-30NS 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 in
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 180
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)
- 3265805 3281660
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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