BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

FDA Device Recall #Z-0136-2024 — Class II — September 26, 2023

Recall Summary

Recall Number Z-0136-2024
Classification Class II — Moderate risk
Date Initiated September 26, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm B. Braun Medical, Inc.
Location Allentown, PA
Product Type Devices
Quantity 175,000 units

Product Description

BULK LARGEBORE MALE LL FITTING, Article No. M4341750SN. IV administration component.

Reason for Recall

Devices may leak as a result of a manufacturing issue. Leakage may result in a delay of therapy, increase risk of bloodstream infection (BSI), and may expose both patients and healthcare workers to hazardous medication. There is also the potential for life-threatening situations to occur requiring additional medical intervention.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada and Singapore.

Lot / Code Information

UDI-DI: N/A Lot 0061744741, 0061749486

Other Recalls from B. Braun Medical, Inc.

Recall # Classification Product Date
Z-1021-2025 Class II Design Options COMBINED SPINAL/EPIDURAL TRAY- ... Dec 4, 2024
Z-3144-2024 Class II AET36 ANESTH EXT SET - Anesthesia Extension Set... Aug 8, 2024
Z-2387-2024 Class II Infusomat SPACE PUMP IV SET, 2 CARESITES, ASV-U... Jun 17, 2024
Z-2380-2024 Class II Infusomat 60DROP METRISET PUMP SET, 3 SAFELINE... Jun 17, 2024
Z-2391-2024 Class II Infusomat UNIV. 15 DR PUMP SET, 1.2FIL, 2CRSTE... Jun 17, 2024

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.