ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 560 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 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 560 units of the Cardiac Catheterization Waste Management System Left Heart Kit, Item No. 46073-14. The recall involves the SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. These products were distributed nationwide.
The recall was initiated because ICU Medical identified a potential for leak with the affected kits. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line.
The source text does not specify specific lot numbers, expiration dates, or reported injuries. Consumers and healthcare facilities should check their inventory for the affected Item No. 46073-14 and contact ICU Medical for instructions on how to proceed.
The recalled product
- Product
- CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 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 el
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 560
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)
- 3226637 3264129
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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