ONE-LINK Needle-free IV Connector, Product Codes: 7N8300, 7N8301, 7N8310, 7N8330K, 7N8332K, 7N833...
FDA Device Recall #Z-0794-2020 — Class II — December 12, 2019
Recall Summary
| Recall Number | Z-0794-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | December 12, 2019 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Baxter Healthcare Corporation |
| Location | Deerfield, IL |
| Product Type | Devices |
| Quantity | 43,495,400 units |
Product Description
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 drugs and solutions without needles, thus eliminating the potential for needle-stick injuries during use. This device is an in-line injection site which can be connected to standard male Luer adapters (e.g., syringes or sets) for the continuous or intermittent fluid administration or the withdrawal of fluids.
Reason for Recall
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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and countries of Bermuda, Bahamas, Trinidad and Tobago, Grand Cayman, St. Thomas, Guyana and Barbados, Mexico, Canada, and New Zealand.
Lot / Code Information
PRODUCT CODE UDI 7N8300 85412091839 7N8301 85412475387 7N8301K 85412499635 7N8310 85412476728 7N8330K 85412613499 7N8332K 85412599625 7N8334K 85412613482 7N8370K 85412613505 7N8371 85412091822 7N8375K 85412613475 7N8376K 85412599601 7N8377 85412091808 7N8378 85412091792 7N8390 85412475417 7N8391 85412475400 7N8399 85412091785 7N8399K 85412478227 All Lots
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|---|---|---|---|
| Z-2262-2026 | Class II | Brand Name: Exacta Mix Product Name: Vented Mi... | Apr 22, 2026 |
| Z-1573-2026 | Class II | Brand Name: Welch Allyn, Inc. Product Name: We... | Feb 18, 2026 |
| Z-1637-2026 | Class I | Blue Ventilator Adapter Module, single-patient ... | Feb 18, 2026 |
| Z-1368-2026 | Class II | Brand Name: Spectrum IQ Product Name: Infusion... | Jan 13, 2026 |
| Z-1121-2026 | Class II | SIGMA Spectrum Infusion Pump, Model/Catalog Num... | Nov 28, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.