ICU Medical Recalls Transpac IV Transducers Due to Potential Leak
ICU Medical is recalling 120 units of Transpac IV transducers and SafeSet Reservoir kits 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 hazard where injury has not yet been reported, fitting the criteria for a risk-of-harm product without reported illness.
Plain-English summary
ICU Medical, Inc. is recalling 120 units of BIFURCATED TRANSPAC 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34. The product is a Transpac Disposable Straight Pressure Transducer (DSPT) that interfaces between a catheter and pressure monitor. The recall also involves SafeSet Reservoir and blood sampling kits containing these transducers.
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 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 source text does not specify specific lot numbers, expiration dates, or reported illnesses or injuries associated with this recall.
The recalled product
- Product
- BIFURCATED TRANSPAC¿ 4 WITH 03ML FLUSH DEVICE FOR BUFFALO GENERAL HOSP., Item No. 46063-34 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
- 120
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)
- 3235523
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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