ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 30 units of 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 involves a medical device with a potential leak, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 30 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product involved is the Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19. 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 a blood sampling system assembled directly to the patient monitoring line.
The recall was initiated because ICU Medical identified a potential for leak with these specific kits. The affected units are identified by the codes 3245753 and 3268530. The products were distributed nationwide.
The source text does not specify the exact actions consumers or healthcare providers should take, nor does it report any specific injuries or illnesses associated with the leak. Users of these medical devices should consult their healthcare providers or the manufacturer for specific guidance on handling the recalled items.
The recalled product
- Product
- Cath Lab Kit w/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 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
- 30
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)
- 3245753 3268530
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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