ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 880 Transpac IV transducers and SafeSet Reservoir kits due to a potential for leak. The 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 source identifies a potential leak in a medical device without reporting specific injuries or illnesses. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (3).
Plain-English summary
ICU Medical, Inc. is recalling 880 units of TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20. These products, which include the Transpac Disposable Straight Pressure Transducer (DSPT) and SafeSet Reservoir blood sampling kits, were distributed nationwide.
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 transducers are extravascular devices that interface between a catheter and a pressure monitor to convert pressure changes into electrical currents.
Healthcare facilities and consumers who have these specific products should stop using them and contact ICU Medical for further instructions. The agency classification for this recall is Class II.
The recalled product
- Product
- TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pressur
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 880
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)
- 3279215
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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