ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
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 leak hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The affected products are identified by code 3288582 and were distributed nationwide.
The recall was initiated because the company identified a potential for leak with these specific kits. The Transpac IV transducer is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.
Healthcare providers and consumers should stop using the affected units immediately. No specific instructions for return or disposal are provided in the source text, but users should contact the manufacturer or their supplier for further guidance.
The recalled product
- Product
- 4 Port "ON" Manifold (600 psi) w/4 ft. Transpac¿ IV, Item No. 46300-14NS 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
- 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)
- 3288582
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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