Use caution Medical device recall · FDA · Published December 21, 2020

Baxter ONE-LINK Catheter Extension Set Recall: Risk of Tubing Separation

Baxter recalls ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to customer reports of tubing separation from the Male Luer Lock Adaptor. Affected units have specific lot numbers and expiration dates.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-1102-2021Medical device Baxter ›

Use caution until it’s fixed

There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

Take action

Contact the company

Recalling firmBaxter Healthcare Corporation1 Baxter Pkwy · Deerfield, IL 60015-4625

✎ GovInfoNow plain-language explainer

Baxter is recalling ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets after customer reports of tubing separating from the Male Luer Lock Adaptor. This could lead to improper IV connections and potential complications during medical treatment. Read more at govinfonow.com/recall/63635-baxter-one-link-catheter-extension-set-recall-risk-of-tubing.

Source Summary by GovInfoNow · govinfonow.com/recall/63635-baxter-one-link-catheter-extension-set-recall-risk-of-tubing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1102-2021

Cite this page

“Baxter ONE-LINK Catheter Extension Set Recall: Risk of Tubing Separation.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63635-baxter-one-link-catheter-extension-set-recall-risk-of-tubing. Based on FDA recall #Z-1102-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1102-2021%22&limit=1).

The FDA announced on Dec. 21, 2020, that Baxter Healthcare Corporation voluntarily recalled its ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Sets due to potential tubing separation. The agency classified the recall as Class II.

How to tell if you have it

Brand: Baxter
Product: Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm)
REF: 7N8370K
Lot Numbers: DR18E01023, DR18E07053, DR19G08023, DR19H07015, DR19L09030, DR20B04020
Distribution: US Nationwide in SC, OH, MI, CA, TX; UK, Ireland

The hazard

There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

Context

GovInfoNow's records show Baxter Healthcare Corporation has 187 other recalls on record since Sept. 2, 2015. Other recent recalls include the Baxter Healthcare PRO+ 40" MRS SURFACE Mattress Recall (Aug. 18, 2026) and the Baxter 0.9% Sodium Chloride Injection Recall (Aug. 17, 2026). Similar recent recalls of IV extension sets include the B Braun Medical IV Extension Set Recall (Oct. 29, 2025).

How to tell if you have this one

Check for the product name 'Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set' with lot numbers DR18E01023, DR18E07053, DR19G08023, DR19H07015, DR19L09030, or DR20B04020. The expiration dates range from May 2, 2023 to February 5, 2025.

Brand
Baxter
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the lot number and expiration date on the product label to confirm if it is affected.
Contact Healthcare Provider
If you have the affected product, contact your healthcare provider for guidance on next steps.

Where it went and when

Where it was distributed

Distributed nationwide and abroad; the notice names 5 states.

FDA distribution: “Worldwide distribution - US Nationwide distribution in the states of SC, OH, MI, CA, TX, and the countries of UK, Ireland.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: California, Michigan, Ohio, South Carolina, Texas.

Recall timeline

FDA terminated this recall 3.6 years after the firm started it.

Dec 21, 2020Firm started the recall
Feb 9, 2021FDA classified it Class II
Feb 17, 2021Published in FDA’s Enforcement Report
Jul 11, 2024FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Baxter recalls

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Keep exploring

More Baxter recalls

Link to this recall

<a href="https://govinfonow.com/recall/63635-baxter-one-link-catheter-extension-set-recall-risk-of-tubing">Baxter ONE-LINK Catheter Extension Set Recall: Risk of Tubing Separation (GovInfoNow)</a>

Where this comes from

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.

Official source: FDA Recall #Z-1102-2021 (December 21, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1102-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.