ICU Medical Recalls SafeSet Reservoir Kits Due to Leak Risk
ICU Medical is recalling 120 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 leak hazard. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
ICU Medical, Inc. is recalling 120 units of CATH LAB KIT, Item No. 46096-25, which includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system. The SafeSet Reservoir is a blood sampling system used on patients where periodic blood sampling is required. The affected products were distributed nationwide.
The recall was initiated because ICU Medical identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The specific lot codes associated with this recall are 3281286, 3288479, and 3310930.
Healthcare facilities and consumers should check their inventory for these specific item numbers and lot codes. If the products are found, they should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for consumer action are provided in the source text beyond the identification of the defect.
The recalled product
- Product
- CATH LAB KIT, Item No. 46096-25 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 that can be input into a compati
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 120
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)
- 3281286 3288479 3310930
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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