ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 1,100 Transpac IV Monitoring Kits with SafeSet Reservoirs due to a potential leak. The kits were distributed nationwide.
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 is a potential leak in a medical device used for patient monitoring and blood sampling, which poses a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling 1,100 units of the Transpac IV Monitoring Kit with SafeSet Reservoir and 2 Blood Sampling Ports, 60" Tubing, Disposable Transducer, 3 mL Intraflo Flush, Macrodrop (Pole Mount), Item No. 42645-06. The recall involves the Transpac Disposable Straight Pressure Transducer (DSPT), which is an extravascular pressure transducer that interfaces between a catheter and pressure monitor.
The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. 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.
The affected products were distributed nationwide. The source text does not specify a date range for distribution or report any illnesses or injuries associated with the defect.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT WITH SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML INTRAFLO¿ FLUSH, MACRODRIP (POLE MOUNT), Item No. 42645-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 1,100
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)
- 3243142
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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