ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 740 units of Transpac IV Bifurcated 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 classified as High.
Plain-English summary
ICU Medical, Inc. is recalling 740 units of the Transpac IV Bifurcated Monitoring Kit, Item No. 42652-05. The product is a 72-inch kit that includes two disposable transducers and two 3 mL squeeze flushes, designed for macrodrip pole mount use. The kits were distributed nationwide.
The recall was initiated because the company identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers. The SafeSet Reservoir system is a blood sampling system assembled directly to the patient monitoring line, used on patients where periodic blood sampling is required.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical, Inc. for further instructions or a replacement. The recall is classified as Class II by the FDA.
The recalled product
- Product
- TRANSPAC¿ IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCERS, 2 3 ML SQUEEZE FLUSH, MACRODRIP (POLE MOUNT), Item No. 42652-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pr
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 740
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)
- 3265462
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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