ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 500 units of Monitoring Kit #3 with SafeSet Reservoirs due to a potential leak. The kits are 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 involves a medical device with a potential leak hazard where no injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 500 units of Monitoring Kit #3 with 0.3 ml Flush Device for Children's Hospital, Item No. 46010-34. The product includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir blood sampling system. These kits are used to interface between a catheter and a pressure monitor and to sample blood from patients.
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 affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- Monitoring Kit #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 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
- 500
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)
- 3226573
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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