ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 40 SafeSet Reservoir and blood sampling kits containing Transpac IV transducers due to a potential for leaks.
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 is classified as FDA Class II and involves a medical device with a potential for leaks, which poses a risk of harm to patients, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 40 units of SafeSet Reservoir and blood sampling kits that contain Transpac IV transducers. The specific product is the Monitoring Kit with 03ml Flush Device for NYU Med Ctr, Item No. 46094-37. The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor, while the SafeSet Reservoir system is used for periodic blood sampling on patients.
The recall was initiated because ICU Medical identified a potential for leaks with these specific kits. The affected units are associated with codes 3242482 and 3265564. The agency classification for this recall is Class II.
The affected products were distributed nationwide. Consumers and healthcare facilities should check their inventory for the specific item number and codes listed above. If the product is found, it should be removed from use and returned to the supplier or the manufacturer in accordance with standard recall procedures.
The recalled product
- Product
- MONITORING KIT WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 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
- 40
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)
- 3242482 3265564
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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