ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
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 for 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 where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of Monitoring Kits with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve (Item No. 46112-65). The affected products are SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers.
The recall was initiated because the company identified a potential for leak with these specific kits. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
The affected units are identified by lot number 3265807. The products were distributed nationwide in the United States. The source text does not specify the exact number of affected units beyond the 20 units listed in the structured data, nor does it report any specific injuries or illnesses associated with the leak.
The recalled product
- Product
- Monitoring Kit with TP4, 30 ml Squeeze Flush Device, 10 cc Contamination Syringe and Needleless Valve, Item No. 46112-65 Product Usage: The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and
- 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)
- lot number 3265807
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 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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