ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 40 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 no injuries or illnesses have been reported, fitting the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 40 units of Right Heart Cath Lab Kits, Item No. 46100-87, which include SafeSet Reservoir and blood sampling kits containing Transpac IV transducers. The recall was initiated because the company identified a potential for leak in these specific kits.
The affected products were distributed nationwide. The kits are used in medical settings to interface with catheters and pressure monitors for blood sampling and pressure monitoring.
Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- Right Heart Cath Lab Kit w/2 Port "OFF" Manifold (600 psi), 72" Spike Set, Transpac¿ IV and 48" HP Tubing, Item No. 46100-87 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monito
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 40
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)
- 3251051
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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