ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Potential
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, which poses a risk of harm to patients, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 40 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product identified is the Neonatal Kit with 30ml Flush Device for Yale-New Haven Hospital, Item No. 46068-65. 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 source text does not specify the exact nature of the leak (e.g., fluid leakage vs. air ingress) or whether any adverse events have occurred.
The affected units were distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific item number and code 3265497. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local medical waste regulations, as directed by the recalling firm.
The recalled product
- Product
- NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 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 elec
- 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)
- 3265497
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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