ICU Medical Recalls Trifurcated Transpac IT Monitoring Kits Due to Leak Risk
ICU Medical is recalling 40 units of Trifurcated Transpac IT 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 defect that may cause a fluid leak, representing a risk of harm where injury has not yet been reported, which aligns with the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling 40 units of Trifurcated Transpac IT Monitoring Kits, Item No. 011-46104-33, Lot No. 2873662. The product is a medical device intended for measuring and monitoring fluid pressure, fluid infusion, and blood withdrawal.
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. This defect may cause a fluid leak.
The affected units were distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers should stop using the affected monitoring kits and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Monitoring Kit
- Affected units
- 40
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)
- Lot No. 2873662
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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