ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 20 units of Transpac IV Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling kits.
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 rubric for risk-of-harm products without reported illness.
Plain-English summary
ICU Medical, Inc. is recalling 20 units of the Transpac IV Monitoring Kit, Item No. 46104-63. The product includes a 60-inch disposable transducer, 30 mL Intraflo flush, Pall air filter, and Macrodrip pole mount. The recall is limited to units with code 3249845.
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 specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo¿ Flush, Pall Air Filter, Macrodrip (Pole Mount), Item No. 46104-63 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — IV Monitoring
- Hazard
- Affected units
- 20
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)
- 3249845
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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