ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 160 units of Transpac IV transducer kits due to a potential leak. The affected products were 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, which is a risk-of-harm product where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 160 units of the TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U. (Item No. 46080-38). This product includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for blood sampling on patients requiring periodic sampling.
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 affected units were distributed nationwide.
The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this defect.
The recalled product
- Product
- TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 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 electric
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 160
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)
- 3226654
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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