ICU Medical Recalls MicroClave T-Connectors Due to Connection Separation Risk
ICU Medical is recalling specific MicroClave T-Connectors because they may separate, causing fluid leakage. The recall affects 250 units distributed in nine US states.
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 risk of harm (leakage due to separation) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
ICU Medical, Inc. is recalling 250 units of MicroClave T-Connectors. The affected products are part of the 119" (302 cm) Transfer Set with MicroClave T-Connector, Smallbore Quadfuse Ext Set with 3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037. These devices are intended for the infusion and withdrawal of fluids and are provided sterile.
The recall was initiated because the T-Connectors have potential connection separation issues that could lead to leakage. The affected units are identified by Lot Nos. 2977625, 2992751, and 2995225.
The products were distributed nationwide in the United States, specifically in South Carolina, North Carolina, Minnesota, Connecticut, Kentucky, Maryland, Florida, Virginia, and Tennessee. Healthcare facilities and consumers should stop using the affected devices and contact ICU Medical for further instructions.
The recalled product
- Product
- 119" (302 cm) Transfer Set w/MicroClave T-Connector, Smallbore Quadfuse Ext Set w/3 MicroClave (Red, Glow Rings), 5 Check Valves, 0.2 Micron Filter, Rotating Luer, Non-DEHP Tubing, Item No. B33037 Product Usage: IV Administration sets are intended for the infusion and withdra
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 250
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. 2977625 2992751 2995225
Distribution
Part of a larger recall action
This product is one of 8 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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