ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 30 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 is classified as FDA Class II and involves a potential leak in a medical device used for blood sampling and pressure monitoring. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High.
Plain-English summary
ICU Medical, Inc. is recalling 30 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers. The specific product identified is the HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59, with code 3265513. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor, while 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 these specific kits. The agency classification for this recall is Class II. The affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected SafeSet Reservoir and blood sampling kits immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or dispose of the product.
The recalled product
- Product
- HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 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 cu
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 30
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)
- 3265513
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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