ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling specific Transpac IV transducers with SafeSet Reservoirs due to a potential for leak.
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 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 where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 260 units of the Transpac IV Disposable Transducer with 4 ft. Cable Extension and 1 Way FM-FM Stopcock (Item No. 46104-35). The recall involves specific SafeSet Reservoir and blood sampling kits that contain these transducers.
The recall was initiated because ICU Medical identified a potential for leak with the affected products. The Transpac Disposable Straight Pressure Transducer is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
The affected units were distributed nationwide. The specific lot codes associated with this recall are 3268549, 3269902, 3284456, and 3310919. Healthcare facilities and consumers should check their inventory for these specific item numbers and lot codes. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- TRANSPAC¿ IV DISPOSABLE TRANSDUCER WITH 4 FT. CABLE EXTENSION AND 1 WAY FM-FM STOPCOCK, Item No. 46104-35 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting cha
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 260
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)
- 3268549 3269902 3284456 3310919
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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