ICU Medical Recalls Transpac IV Transducers Due to Leak Risk
ICU Medical is recalling 4,580 units of Transpac IV Disposable Transducers with Stopcocks due to a potential leak in the SafeSet Reservoir and blood sampling kits.
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 is classified as FDA Class II. The hazard is a potential leak in a medical device used for blood sampling, which poses a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
ICU Medical, Inc. is recalling 4,580 units of the Transpac IV Disposable Transducer with Stopcocks (Item No. 42582-06). The product is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The recall involves specific SafeSet Reservoir and blood sampling kits assembled to the patient 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 SafeSet Reservoir system is used on patients where periodic blood sampling is required.
The affected units were distributed nationwide. The recall covers units with the following codes: 3253195, 3264105, 3265427, 3274783, and 3280951. The source text does not specify specific actions for consumers or healthcare providers beyond the identification of the defect.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH STOPCOCKS, Item No. 42582-06 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 curr
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 4,580
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)
- 3253195 3264105 3265427 3274783 3280951
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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