ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV monitoring kits because the SafeSet Reservoir and blood sampling components may 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 hazard where injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 2,240 units of the Transpac IV Monitoring Kit, Item No. 42607-05. The affected products are identified by codes 3195741 and 3280973 and were distributed nationwide. The kits include a disposable transducer, 3 ml squeeze flush, and microdrip pole mount.
The recall was initiated because the company 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 source text does not specify the exact action consumers or healthcare providers should take, such as whether to stop using the product or contact the manufacturer. It also does not report any specific injuries or illnesses associated with the leak.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MICRODRIP¿ (POLE MOUNT), Item No. 42607-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 2,240
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)
- 3195741 3280973
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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