ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 2,200 Transpac IV Monitoring Kits because of a potential leak in the SafeSet Reservoir and blood sampling components.
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 no specific injuries or illnesses have been reported, fitting the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 2,200 units of the Transpac IV Monitoring Kit SafeSet Reservoir and 2 Blood Sampling Ports, 60" Tubing, Disposable Transducer, 3 ML Squeeze Flush, Macrodrop (Pole Mount), Item No. 42644-06. 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 affected products were distributed nationwide. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor, while the SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line for patients requiring periodic blood sampling.
Healthcare providers and consumers should stop using the affected kits and contact ICU Medical, Inc. for further instructions or a replacement.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT SAFESET" RESERVOIR AND 2 BLOOD SAMPLING PORTS, 60" TUBING, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42644-06 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that i
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 2,200
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)
- 3260808
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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