ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 10 units of 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 for 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 10 units of Trifurcated Transpac IV transducers with 0.3 ml Squeeze Flush Devices, 130" SafeSet Reservoir, and Needleless Valve (Item No. 46108-36). The recall is due to a potential for leak identified in certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
The affected products are extravascular pressure transducers that interface 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 recall involves nationwide distribution. The source text does not specify specific dates, lot numbers, or reported injuries.
The recalled product
- Product
- Trifurcated Transpac¿ IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir and Needleless Valve, Item No. 46108-36 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by c
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 10
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)
- 3257011
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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