ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 25 units of Transpac IV 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 involves a medical device with a potential leak, which poses a risk of harm to patients. 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 25 units of Transpac IV Monitoring Kits, Item No. 46113-91. These kits include an 84-inch Red Stripe Tubing and a 0.3 ml Squeeze Flush Device. The product is a disposable straight pressure transducer that interfaces between a catheter and a pressure monitor, featuring a SafeSet Reservoir system for blood sampling.
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 source text does not specify the exact mechanism of the leak or report any specific injuries or illnesses associated with the defect.
The affected units were distributed nationwide. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items, such as whether to stop use immediately or contact the manufacturer for a replacement.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit w/84" Red Stripe TBG and 03 ml Squeeze Flush Device, Item No. 46113-91 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting changes in
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 25
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)
- 3226952
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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