ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 235 units of SafeSet Reservoir and blood sampling kits containing Transpac IV transducers 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 235 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product identified is the Monitoring Kit with 30 ml Flush Device for Egleston Hospital, Item No. 46094-50. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor by converting pressure changes into electrical currents.
The recall was initiated because ICU Medical identified a potential for leak with these specific kits. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line and is used on patients where periodic blood sampling is required.
The affected units were distributed nationwide. The source text does not specify the exact dates of distribution or the specific facilities affected beyond the nationwide distribution pattern. Consumers and healthcare facilities should stop using the affected kits and contact ICU Medical for further instructions or a replacement.
The recalled product
- Product
- MONITORING KIT W/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 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
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 235
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)
- 3226738
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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