ICU Medical Recalls Transpac Pressure Kits Due to Leak Risk
ICU Medical is recalling 10 units of Transpac pressure kits due to 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 injury has not yet been reported, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling 10 units of the Transpac Disposable Straight Pressure Transducer (DSPT) triple pressure kits, Item No. 46072-51. These kits include a 0.3ml flush device and are designed to interface between a catheter and a pressure monitor. The specific units involved are associated with the code 3267623.
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 used for periodic blood sampling on patients connected to the monitoring line.
The affected units were distributed nationwide. Healthcare facilities and consumers should stop using these specific kits and contact ICU Medical for further instructions or replacement.
The recalled product
- Product
- TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in press
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 10
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)
- 3267623
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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