ICU Medical Recalls 98-inch Transfer Sets Due to Connection Separation
ICU Medical is recalling 50 units of 98-inch Transfer Sets because potential connection separation 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 due to connection separation) where no injuries or illnesses have been reported, fitting the criteria for a High severity score.
Plain-English summary
ICU Medical, Inc. is recalling 50 units of 98" (249 cm) Transfer Sets with MicroClave T-Connectors, 2 Check Valves, Luer Lock, and Non-DEHP Tubing (Item No. B3372). The affected units are identified by Lot No. 3019521.
The recall is being issued because the MicroClave T-Connectors have potential connection separation issues that could lead to leakage. These IV administration sets are intended for the infusion and withdrawal of fluids and are provided sterile.
The affected products were distributed nationwide in the US, specifically in South Carolina, North Carolina, Minnesota, Connecticut, Kentucky, Maryland, Florida, Virginia, and Tennessee. Consumers and healthcare facilities should stop using the affected units and contact the manufacturer for further instructions.
The recalled product
- Product
- 98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 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
- 50
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. 3019521
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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