ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 135 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 risk-of-harm product (medical device leak) where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 135 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product is the Cath Lab Kit w/Waste Bag, dyePod, Sosa Spike & Syringe, Item No. 46098-11. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor by converting pressure changes into electrical currents. 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 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 distribution pattern is listed as Nationwide Distribution, and the code information provided is 3256966.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any illnesses or injuries associated with the leak. Users of these medical devices should refer to official FDA or manufacturer communications for specific instructions on how to handle the recalled units.
The recalled product
- Product
- Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 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
- 135
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)
- 3256966
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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