ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 60 units of Transpac pressure transducer kits due to a potential leak in the SafeSet Reservoir system.
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 criteria for a risk-of-harm product without reported illness.
Plain-English summary
ICU Medical, Inc. is recalling 60 units of the KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49. These kits contain the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling on patients.
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 product was distributed nationwide.
The source text does not specify specific actions for consumers or patients, nor does it report any illnesses or injuries associated with the leak.
The recalled product
- Product
- KIT FOR UNIVERSITY OF MICH. MOTT CATH LAB, Item No. 46061-49 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 electrical currents tha
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 60
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)
- 3256122
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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