ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 80 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers 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 for leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 80 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The recall is being conducted because the company identified a potential for leak with these specific kits.
The affected products are the SafeSet Reservoir system, which is a blood sampling system assembled directly to the patient monitoring line, and the Transpac Disposable Straight Pressure Transducer (DSPT). These devices are used to interface between a catheter and a pressure monitor by converting pressure changes into electrical currents.
The recall involves 80 units distributed nationwide. Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 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 ca
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 80
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)
- 3242450
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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