ICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling specific Transpac IV monitoring kits because the SafeSet Reservoir and blood sampling components may leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 hazard where no specific injuries or illnesses have been reported, fitting the criteria for a risk-of-harm product where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling specific lots of the Transpac IV Monitoring Kit, Item No. 46104-10. The recall involves 1,740 units that were distributed nationwide. The kits include a disposable straight pressure transducer and a SafeSet Reservoir system used for blood sampling.
The recall was initiated because ICU Medical identified a potential for leaks in certain SafeSet Reservoir and blood sampling kits that contain the Transpac IV transducers. The product is an extravascular pressure transducer that interfaces between a catheter and a pressure monitor.
Healthcare facilities and consumers who have these specific kits should stop using them and contact ICU Medical for further instructions. The affected product codes are 3226843 and 3264741.
The recalled product
- Product
- TRANSPAC¿ IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP AND RED PLUGS, Item No. 46104-10 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 1,740
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)
- 3226843 3264741
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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Similar recalls
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