ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 90 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir.
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 90 units of the Double Line Kit with 0.3ml Flush Device & SafeSet, Item No. 46099-18. These kits contain the Transpac Disposable Straight Pressure Transducer (DSPT), which is used to interface between a catheter and a pressure monitor, and the SafeSet Reservoir system for blood sampling.
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 affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical, Inc. for instructions on return or replacement.
The recalled product
- Product
- DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 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 currents
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 90
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)
- 3226777
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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