Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0794-2020·Announced 2020-01-15

Baxter Recalls One-Link Needle-Free IV Connectors Due to Connection Force Issue

Baxter Healthcare is recalling One-Link Needle-Free IV Connectors because some units require higher-than-expected force to connect securely to standard Luer adapters.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a functional defect requiring higher connection force without reporting any injuries, illnesses, or fatalities, fitting the criteria for a moderate severity precautionary recall.

Plain-English summary

Baxter Healthcare Corporation is recalling approximately 43,495,400 units of One-Link Needle-Free IV Connectors. The recall involves specific product codes including 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, and 7N8399. The affected devices are intended for single patient use with a vascular access device for the administration of drugs and solutions without needles.

The recall is due to a manufacturing issue where Continu-Flo sets with male Luer bodies at the lower end of, and within, 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 affects all lots of the specified product codes.

The affected products were distributed worldwide, including the United States, Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana, Barbados, Mexico, Canada, and New Zealand. Healthcare facilities and distributors should stop using the affected devices and contact Baxter Healthcare Corporation for further instructions on returns or replacements.

The recalled product

Product: ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399 - Product Usage: intended for single patient use with a vascular access device for the administration of…
Manufacturer: Baxter Healthcare Corporation
Category: Medical Device — IV Connectors
Hazard: connection-defect
Affected units: 43,495,400

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