ICU Medical Recalls Arterial Monitoring Kits Due to Fluid Leak Risk
ICU Medical is recalling specific 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 is classified as FDA Class II and involves a risk-of-harm product (fluid leak in a medical device) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
ICU Medical, Inc. is recalling 640 units of Single Line Transpac IV Monitoring Kits and Transpac Trifurcated monitoring kits. The affected products include Item No. 011-46108-38 and are identified by Lot Nos. 2817530, 2852405, 2869455, and 2883663. 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 an arterial monitoring kit may crack. This defect can cause a fluid leak. The agency classification for this recall is Class II.
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 lots and contact the manufacturer for further instructions.
The recalled product
- Product
- Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fl
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 640
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. 2817530
- 2852405
- 2869455
- 2883663
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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