ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling specific SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.
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 is classified as FDA Class II. The hazard involves a potential leak in a medical device used for blood sampling and pressure monitoring, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling specific SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The recall involves 370 units of the Monitoring Kit with 03ml Flush Device for Christ Hospital, Item No. 46054-42, which were distributed nationwide. The affected products are identified by codes 3231359 and 3264121.
The recall was initiated because ICU Medical identified a potential for leaks in these specific kits. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
Healthcare facilities and consumers should check their inventory for the specific item number and codes listed above. If the affected products are found, they should be removed from use and returned to ICU Medical, Inc. according to the company's instructions.
The recalled product
- Product
- MONITORING KIT WITH 03ML FLUSH DEVICE FOR CHRIST HOSPITAL, Item No. 46054-42 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 electri
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 370
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)
- 3231359 3264121
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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