ICU Medical Recalls Transpac Pressure Transducer Kits Due to Leak Risk
ICU Medical is recalling 130 units of Transpac pressure transducer kits due to a potential leak. The devices are used for monitoring pressure and blood sampling.
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 potential leak in a medical device used for blood sampling, which poses a risk of harm, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 130 units of the Single A Line Kit CC5 with 0.3ml Flush Device for Albert Einstein M.C., Item No. 46047-17. The product includes the Transpac Disposable Straight Pressure Transducer (DSPT) and the SafeSet Reservoir system. These devices are used to interface between a catheter and a pressure monitor and to facilitate periodic blood sampling from patients.
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 affected units were distributed nationwide.
Healthcare facilities and consumers should stop using the affected products and contact ICU Medical for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- SINGLE A LINE KIT CC5 W/03ML FLUSH DEVICE FOR ALBERT EINSTEIN M.C., Item No. 46047-17 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 int
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 130
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)
- 3249812
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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