MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ53...
FDA Device Recall #Z-0284-2020 — Class II — April 10, 2019
Recall Summary
| Recall Number | Z-0284-2020 |
| Classification | Class II — Moderate risk |
| Date Initiated | April 10, 2019 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Company |
| Location | Franklin Lakes, NJ |
| Product Type | Devices |
| Quantity | Pending |
Product Description
MaxZero Extension Sets with Needle-less Connector, Product codes MZ1000 MZ1000-07 MZ5301 MZ5302 MZ5303 MZ5304 MZ5305 MZ5306 MZ5307 MZ5309 MZ5310 MZ5312 MZ5313 MZ5316 MZ8001 MZ8002 MZ8003 MZ9266 MZ9267 MZ9272 MZ9273 MZ9274 MZ9275 MZ9276 MZ9277 MZ9278 MZ9279 MZ9280 MZ9281 MZ9283 MZ9287 MZ9288 MZ9289 MZ9290 MZ9292 MZ9293 MZ9294 MZ9300 MZ9301 MZ9302 MZ9313 MZ9323 MZ9324 MZ9325 MZ9326 MZ9327 MZ9329 MZT1003 MZT1004 MZX5302 MZXT5303 MZXT5304 MZX5305 MZX5306 MZXT5306 MZXT5307 MZXT9001 MZXT9003 MZXT9004
Reason for Recall
BD has decided to initiate a voluntary recall due to a confirmed complaint trend for droplets of fluid separating from the sealed surface of the MaxZero connector, following disconnection.
Distribution Pattern
Nationwide domestic distribution. Foreign distribution to Argentina Australia Austria Belgium Brazil Canada Chile China Colombia Croatia Cyprus Czech Republic Denmark Finland France Germany Hungary India Italy Japan Jordan Kuwait Lebanon Mexico Morocco Netherlands Norway Oman Poland Qatar Saudi Arabia Singapore Slovenia South Korea Spain Sweden Switzerland Thailand Turkey UAE United Kingdom.
Lot / Code Information
All lots manufactured still within expiry.
Other Recalls from Becton Dickinson & Company
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|---|---|---|---|
| Z-1496-2026 | Class II | 10mL Non-Sterile BD Luer-Lok Tip Syringe Only. ... | Jan 27, 2026 |
| Z-0504-2026 | Class II | BD Luer Tip Caps; Catalog Number(s) or Model N... | Oct 14, 2025 |
| Z-0736-2024 | Class II | PosiFlush Prefilled Saline Syringe with General... | Nov 16, 2023 |
| Z-0349-2024 | Class II | BD Alaris Pump infusion sets (Product Name, Cat... | Oct 11, 2023 |
| Z-0351-2024 | Class II | BD Extension Sets (Product Name, Catalog #) ... | Oct 11, 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.