ICU Medical Recalls Trifurcated Transpac IV Monitoring Kits Due to Leak Risk
ICU Medical is recalling 60 units of Trifurcated Transpac IV Monitoring Kits because a component connection may crack and cause a fluid leak.
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 risk of fluid leak, which poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
ICU Medical, Inc. is recalling 60 units of the Trifurcated Transpac IV Monitoring Kit with Safeset Reservoir, 03 ml Squeeze Flush, and 6 Needleless Valves (Item No. 011-46106-22). The affected lots are 2848741, 2859329, 2862831, and 2869453.
The recall was initiated because ICU Medical became aware of an issue with a component where the connection on the arterial monitoring kit may crack and cause a fluid leak. The monitoring kit is intended for measuring and monitoring of fluid pressure, fluid infusion, and blood withdrawal.
The affected products were distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers should stop using the affected kits and contact ICU Medical for further instructions.
The recalled product
- Product
- Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montori
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 60
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 (4)
- Lot No. 2848741
- 2859329
- 2862831
- 2869453
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 9 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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