ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 1,320 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 hazard where no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products without reported harm.
Plain-English summary
ICU Medical, Inc. is recalling 1,320 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The affected products are identified by lot codes 3226745 and 3245752. These kits include the CATH LAB KIT w/3 PORT 'ON' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26.
The recall was initiated because ICU Medical 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 products were distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities where the products were shipped. The source text does not report any illnesses or injuries associated with this recall.
Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- CATH LAB KIT w/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 1,320
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)
- 3226745 3245752
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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