ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV Monitoring Kits because of 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 the hazard involves a potential leak in a medical device used for blood sampling, which poses a risk of harm without reported injuries, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of Transpac IV Monitoring Kits, Item No. 42585-05. The recall involves 17,420 units that were distributed nationwide. The affected products include the Transpac Disposable Straight Pressure Transducer and the SafeSet Reservoir blood sampling system.
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 any reported adverse health events.
Healthcare providers and consumers should check their inventory for the specific lot codes listed in the recall notice: 3235444, 3238904, 3243135, 3247867, 3247901, 3247902, and 3261560. If these specific units are in use, they should be removed from service and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- Transpac¿ IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush, Macrodrip, Item No. 42585-05 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting cha
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 17,420
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)
- 3235444 3238904 3243135 3247867 3247901 3247902 3261560
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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