Baxter Recalls Clearlink Continu-Flo Administration Sets Due to Connection Force Issue
Baxter Healthcare is recalling Clearlink System Continu-Flo Administration Sets because some units require higher-than-expected force to connect securely.
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 where a connection defect could lead to a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Baxter Healthcare Corporation is recalling Clearlink System Continu-Flo Administration Sets, specifically product codes 2C8519, 2C8537, and 2C8541. The recall covers 271,014,984 units distributed worldwide, including the United States, Canada, Mexico, and several other countries.
The recall was initiated because Continu-Flo sets with male Luer bodies at the lower end of the ISO specification for outer diameter require a higher than expected connection force to fully inset and securely tighten the Luer to the ONE-LINK connector. This issue may affect the secure connection of the device during use.
Healthcare providers and facilities should stop using the affected product codes and contact Baxter Healthcare for further instructions on replacement or return. Consumers should not use these medical devices if they are in their possession and should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- Clearlink System Continu-Flo Administration Sets, Product Codes: 2C8519, 2C8537, and 2C8541 - Product Usage:For the administration of fluids from a container into the patients vascular system through a vascular access device.
- Manufacturer
- Baxter Healthcare Corporation
- Category
- Medical Device — Infusion Sets
- Affected units
- 271,014,984
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 (6)
- Product Codes: 2C8519
- UDI 00085412048994
- 2C8537
- UDI 00085412048970
- and 2C8541
- UDI 00085412071107 All Lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Baxter Healthcare Corporation 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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