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.
What this means for you
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
- 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 →Related recalls
Same manufacturer · Baxter Healthcare Corporation
See all →- SevereBaxter Recalls Cefazolin Injection Bags Due to Particulate Matter
FDA (Drugs) · 2026-08-19
- HighBaxter Duo-Vent Solution Set Recalled for Air Bubbles in Tubing
FDA (Devices) · 2026-08-19
- SevereHillrom VOLARA System P.CIRCUIT KIT Medical Device Recall for Oxygen Drop Risk
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA P.CIRCUIT Medical Device Nebulizer Cup Leakage Recall
FDA (Devices) · 2026-07-08
- SevereHillrom VOLARA System patient circuits recalled for nebulizer leakage risk
FDA (Devices) · 2026-07-08
Same hazard · connection defect
See all →- SevereCook Blue Rhino G2 Tracheostomy Introducer Trays Recalled for Connection Defect
FDA (Devices) · 2023-05-17
- HighMedical Device Recall: Vascular Diagnostic Device Air Embolism Risk
FDA (Devices) · 2023-03-08
- HighRoadtrek 2021-2022 Motorhomes: Propane Leak Risk From Valve Defect
NHTSA · 2022-07-08
- HighOrthopedic surgical driver oversized, affecting hammertoe correction
FDA (Devices) · 2022-04-20
- HighBaxter Recalls Clearlink Continu-Flo Administration Sets Due to Connection Force Issue
FDA (Devices) · 2020-01-15