ICU Medical Recalls Arterial Monitoring Kits Due to Potential Fluid Leak
ICU Medical is recalling 100 units of Transpac IT arterial monitoring kits because a component connection may crack and cause a fluid leak.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 is a risk-of-harm product where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 100 units of Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP (Item No. 011-46106-96). The affected product is a Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush, and sampling ports, 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 and cause a fluid leak. The affected units are identified by Lot No. 2866974.
The product was distributed worldwide, including in the United States (specifically Oregon) and internationally to Australia. Healthcare facilities and consumers should stop using the affected units and contact ICU Medical for instructions on return or replacement.
The recalled product
- Product
- Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion…
- Manufacturer
- ICU Medical, Inc.
- Hazard
- Affected units
- 100
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. 2866974
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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