ICU Medical Recalls Transpac Pressure Transducers Due to Potential Leak
ICU Medical is recalling 336 units of Transpac pressure transducers and 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 without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 336 units of the Transpac Disposable Straight Pressure Transducer (DSPT) and associated SafeSet Reservoir blood sampling kits. The recall involves specific lots distributed nationwide, including items designated for Portland Adventist Hospital.
The recall was initiated because the company 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, while the SafeSet reservoir is used for periodic blood sampling on patients.
Consumers and healthcare facilities should stop using the affected products immediately. Affected units can be identified by the following codes: 3272733, 3274843, 3284331, and 3293001. For more information, contact the recalling firm, ICU Medical, Inc.
The recalled product
- Product
- LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 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 currents t
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 336
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)
- 3272733 3274843 3284331 3293001
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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