ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 295 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.
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 leaks, which poses a risk of harm to patients, but the source text does not report any 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 295 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product involved is the Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a 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 leaks with these specific kits. The affected units were distributed nationwide. The source text does not specify a date range for distribution or report any illnesses or injuries associated with the defect.
Consumers and healthcare facilities 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 recalled products.
The recalled product
- Product
- Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 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 elec
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 295
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)
- 3226690
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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