ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 20 units of 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 leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers. The affected products are identified by Item No. 46091-13 and code 3245748. These kits include a monitoring kit with a 0.3ml flush device for Concord Hospital and a Transpac Disposable Straight Pressure Transducer (DSPT).
The recall was initiated because ICU Medical identified a potential for leak with these specific kits. The Transpac DSPT is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients connected to the monitoring line.
The affected units were distributed nationwide. Consumers and healthcare facilities should stop using the recalled products and contact ICU Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 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 electrica
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 20
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)
- 3245748
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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