ICU Medical Recalls Arterial Pressure Kits Due to Leak Risk
ICU Medical is recalling 380 arterial pressure kits containing Transpac transducers due to a potential leak risk.
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 risk, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 380 units of Arterial Pressure Kits with 0.3ml Flush Devices for LeBonheur Children's Hospital (Item No. 46091-31). These kits contain the Transpac Disposable Straight Pressure Transducer (DSPT) and SafeSet Reservoir system, which are used to interface between a catheter and a pressure monitor and for periodic blood sampling.
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 products 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
- ARTERIAL PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressur
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 380
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)
- 3231380
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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