ICU Medical Recalls Transpac IV Transducers Due to Leak Risk
ICU Medical is recalling specific Transpac IV transducers and SafeSet Reservoir kits due to a potential for leaks.
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 for leaks, which poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Transpac IV Disposable Transducers and associated SafeSet Reservoir and blood sampling kits. The recall involves 3,060 units that were distributed nationwide. The affected products include Item No. 42582-05, which is an extravascular pressure transducer used to interface between a catheter and a pressure monitor, along with the SafeSet Reservoir system used for periodic blood sampling.
The recall was initiated because ICU Medical identified a potential for leaks 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.
Healthcare facilities and consumers should check their inventory for the affected lot codes (3264104, 3265426, 3274779) and stop using these specific transducers and kits. Users should contact ICU Medical for instructions on how to return or replace the affected products.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER, Item No. 42582-05 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 that can b
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 3,060
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)
- 3264104 3265426 3274779
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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