ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 125 Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.
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 is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for blood sampling, which poses a risk of harm without reported injuries.
Plain-English summary
ICU Medical, Inc. is recalling 125 units of the Transpac Disposable Straight Pressure Transducer (DSPT) and associated SafeSet Reservoir blood sampling kits. The recall involves specific kits, including the Right Heart Kit for NC Baptist Hospital (Item No. 46066-34), which were distributed nationwide.
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. These devices are used to interface between a catheter and a pressure monitor and to facilitate periodic blood sampling from patients.
Healthcare facilities and consumers who have these specific products should stop using them and contact ICU Medical for further instructions. The affected units are identified by the following codes: 3274845, 3281034, 3293002, and 3296790.
The recalled product
- Product
- RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 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 that
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 125
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)
- 3274845 3281034 3293002 3296790
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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