ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 110 units of Double Kit with SafeSet and 03mL Flush Device 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 injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported illness.
Plain-English summary
ICU Medical, Inc. is recalling 110 units of the Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37. The product is a Transpac Disposable Straight Pressure Transducer (DSPT) that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line.
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 are from lot number 3274859 and were distributed nationwide in the United States.
Healthcare facilities and consumers should stop using the affected product immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or dispose of the recalled units.
The recalled product
- Product
- Double Kit with SafeSet and 03mL Flush Device, Item No. 46080-37 Product Usage: 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
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 110
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)
- lot number 3274859
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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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