ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 90 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 (leak in a medical device) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 90 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product is the Monitoring Kit with 0.3ml Flush Device for Medical College of GA, Item No. 46080-51. The Transpac Disposable Straight Pressure Transducer (DSPT) 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.
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 affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected SafeSet Reservoir and blood sampling kits immediately. Users should contact ICU Medical, Inc. for further instructions on how to return or dispose of the recalled products.
The recalled product
- Product
- MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 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…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 90
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)
- 3188653
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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