Agency classClass IIOur severity:High FDA (Devices)·Z-0793-2020·Announced 2020-01-15

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.

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 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
Hazard: connection-defect
device-malfunction
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.

See all 2 products in this recall →

Same manufacturer · Baxter Healthcare Corporation

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Same hazard · connection defect