ICU Medical Recalls SafeSet Reservoir Kits Due to Potential Leak
ICU Medical is recalling 290 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 hazard where no specific injuries or illnesses have been reported in the source text, fitting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 290 units of the Open Heart Monitoring Kit with 03ml Flush Device for Orlando Reg. Med. Ctr., Item No. 46068-48. These kits include the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system, which is used for periodic blood sampling on patients connected to the monitoring line.
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 affected products were distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions or a replacement. The specific lot codes associated with this recall are 3247291 and 3249820.
The recalled product
- Product
- OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in pre
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 290
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)
- 3247291 3249820
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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