ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 60 units of Transpac IV 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 'High' severity criteria for risk-of-harm products without confirmed harm.
Plain-English summary
ICU Medical, Inc. is recalling 60 units of the Transpac Disposable Straight Pressure Transducer (DSPT) and associated SafeSet Reservoir blood sampling kits. The affected items are identified as Cath Lab Kits for Albert Einstein M.C., Item No. 46047-19, with code 3284322. These devices are extravascular pressure transducers that interface between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.
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 nature of the leak or any reported injuries or illnesses associated with this defect.
The affected products were distributed nationwide. Consumers and healthcare facilities should stop using these specific kits and contact ICU Medical for further instructions or replacement.
The recalled product
- Product
- CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 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 ca
- 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)
- 3284322
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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