Baxter recalls ONE-LINK Needle-free IV Connectors with specific product codes due to potential connection issues requiring higher force than expected, which may lead to disconnection during use.
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.
Baxter is recalling specific ONE-LINK Needle-free IV Connectors because they require a higher connection force than expected. This could cause the connector to disconnect during use, potentially leading to medication leaks or other complications.
The connectors have male Luer bodies that require a higher connection force than the ISO specification allows. This can cause the connector to become loose or disconnect during use, potentially leading to medication leaks or other complications.
Healthcare professionals and patients using Baxter ONE-LINK IV Connectors with the listed product codes are affected. Those administering fluids through these connectors are most at risk of disconnection.
Check the product code on the connector, which includes numbers like 7N8300, 7N8301, 7N8310, and others listed in the recall notice. These connectors are used for IV fluid administration without needles.
Identify the product code on the connector, such as 7N8300, 7N8301, 7N8310, or other codes listed in the recall notice.
If the connector has a product code from the recall list, stop using it immediately to prevent potential disconnection.
The affected product codes are 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N8334K, 7N8370K, 7N8371, 7N8375K, 7N8376K, 7N8377, 7N8378, 7N8390, 7N8391, 7N8399, and 7N8399K.
The connectors require a higher connection force than expected, which can cause them to become loose or disconnect during use, potentially leading to medication leaks.
If you have a connector with a product code from the recall list, stop using it immediately and contact Baxter for further instructions.
We’ve drafted a message you can send Baxter to request your refund or repair — edit it as you like.
Subject: Recall Z-0794-2020 — Baxter Baxter Hello, I own a Baxter that is covered by recall Z-0794-2020 from Baxter. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.