Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

FDA Device Recall #Z-0746-2024 — Class II — November 10, 2023

Recall Summary

Recall Number Z-0746-2024
Classification Class II — Moderate risk
Date Initiated November 10, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Smiths Medical Asd Inc
Location Dublin, OH
Product Type Devices
Quantity 31,685 total

Product Description

Medex 20IN (50.8CM) INJ LINE ROTATING ADAPT, List Number MX682R

Reason for Recall

There is a manufacturing defect affecting specific rotator lots. Within this population, the inner diameter of the devices O-ring may be oversized affecting seal integrity. An inadequate seal may lead to a leak during infusion of medication which may potentially lead to under infusion of medication.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, UAE.

Lot / Code Information

Lot Number: 4398433

Other Recalls from Smiths Medical Asd Inc

Recall # Classification Product Date
Z-0747-2024 Class II 48IN (121.9CM) INJ LINE ROTATING ADAPT (900psi)... Nov 10, 2023
Z-0740-2024 Class II 1050 STOPCOCK LEFT ROTATOR OFF HANDLE, List Num... Nov 10, 2023
Z-0743-2024 Class II HIGH PRESSURE ROTATOR WITH MALE LUER LOCK, List... Nov 10, 2023
Z-0744-2024 Class II HIGH PRESSURE ROTATOR WITH FEMALE LUER LOCK, L... Nov 10, 2023
Z-0741-2024 Class II 6IN PRESSURE TUBING, List Number MX20617 Nov 10, 2023

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.