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
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classifies this as a Class II recall involving a structural defect in a medical device that can cause fluid leaks, which aligns with the rubric criteria for Severe severity.
Plain-English summary
ICU Medical, Inc. is recalling 1,560 units of the Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount (Item No. 011-46104-42). The affected lots are 2841944, 2841945, 2859326, 2865873, and 2869445. 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 agency classifies this as a Class II recall.
The affected products were distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers should stop using these specific kits and contact ICU Medical for instructions on how to return or replace the devices.
The recalled product
- Product
- Arterial Safeset Transpac IT w/3 ml Reservoir and Single CSP, With Velcro Arm Strap, Patient Mount, Item No. 011-46104-42 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 1,560
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 (5)
- Lot No. 2841944
- 2841945
- 2859326
- 2865873
- 2869445
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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