ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling 200 arterial monitoring kits because a component connection may crack, causing 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 200 units of the Single Transpac IT Monitoring Kit with 0.3 ml Flush Device, Needleless Valve, and Macrodrip (Item No. 011-46106-29). The recall is limited to Lot No. 2866991. These kits are 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 can cause a fluid leak. 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 monitoring kits immediately. Users should contact ICU Medical for instructions on how to return the product or obtain a replacement.
The recalled product
- Product
- Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure
- Manufacturer
- ICU Medical, Inc.
- Category
- Medical Device — Monitoring Kit
- Hazard
- Affected units
- 200
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. 2866991
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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