ICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
ICU Medical is recalling 120 units of TP4 Monitoring Kits with SafeSet Reservoirs due to a potential leak. The devices are distributed nationwide.
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 injury has not yet been reported, fitting the criteria for a risk-of-harm product without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 120 units of TP4 Monitoring Kits, Item No. 46101-53, which include the Transpac Disposable Straight Pressure Transducer (DSPT) and SafeSet Reservoir. The recall is due to a potential for leak identified in certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
The affected products are extravascular pressure transducers that interface between a catheter and a pressure monitor. The SafeSet Reservoir system is used for periodic blood sampling on patients. The recall covers units distributed nationwide.
Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions. The source text does not report any specific injuries or illnesses associated with this recall.
The recalled product
- Product
- TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless Valve, Item No. 46101-53 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular pressure transducer that interfaces between a catheter and pressure monitor by converting…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 120
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)
- 3249839
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
- HighICU Medical Recalls Transpac IV Transducer Kits Due to Leak Risk
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- HighICU Medical Recalls Transpac IV Monitoring Kits Due to Leak Risk
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