ICU Medical Recalls Transpac IV Trifurcated Monitoring Kits Due to Leak Risk
ICU Medical is recalling 100 units of Transpac IV Trifurcated Monitoring Kits due to a potential leak in the SafeSet Reservoir and blood sampling components.
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 patient monitoring and blood sampling. Per the rubric, risk-of-harm products where injury has not yet been reported are rated High.
Plain-English summary
ICU Medical, Inc. is recalling 100 units of Transpac IV Trifurcated Monitoring Kits, Item No. 46112-05. These kits include a 0.3 ml Squeeze Flush Device, Arterial SafeSet Reservoir, and Needleless Valves. The product is an extravascular pressure transducer system used to interface between a catheter and a pressure monitor, with a blood sampling system assembled directly to the patient monitoring line.
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 product and contact ICU Medical for further instructions or a return. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Transpac¿ IV Trifurcated Monitoring Kit w/03 ml Squeeze Flush Device, Arterial Safeset" Reservoir and Needleless Valves, Item No. 46112-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and p
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Monitoring Kits
- Hazard
- Affected units
- 100
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)
- 3259439
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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