ICU Medical Recalls Transpac Pressure Transducers Due to Leak Risk
ICU Medical is recalling 660 Transpac pressure transducers and SafeSet reservoir kits due to a potential leak hazard.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 rubric criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 660 units of the Transpac Disposable Straight Pressure Transducer (DSPT) and associated SafeSet Reservoir blood sampling kits. The product, identified by Item No. 46086-21, is an extravascular pressure transducer used to interface between a catheter and a pressure monitor. The SafeSet Reservoir system is used for periodic blood sampling on patients connected to the monitoring line.
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 source text does not specify the exact mechanism of the leak or any reported injuries or illnesses associated with the defect.
The affected products were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled units, nor does it list specific lot numbers or expiration dates beyond the provided code information.
The recalled product
- Product
- ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 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…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 660
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)
- 3226664
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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