ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage
ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.
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) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
ICU Medical, Inc. is recalling MicroClave T-Connectors. The recall is due to potential connection separation issues that could lead to leakage.
The affected product is the 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041. These IV administration sets are intended for the infusion and withdrawal of fluids and are provided sterile. The recall involves 600 units from Lot Nos. 3002665, 3004236, and 2995225.
The products were distributed nationwide in the US, specifically in South Carolina, North Carolina, Minnesota, Connecticut, Kentucky, Maryland, Florida, Virginia, and Tennessee. Consumers and healthcare providers should stop using the affected devices and contact ICU Medical for further instructions.
The recalled product
- Product
- 107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
- Manufacturer
- ICU Medical, Inc.
- Affected units
- 600
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. 3002665 3004236 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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