BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing...
FDA Device Recall #Z-1016-2024 — Class II — January 8, 2024
Recall Summary
| Recall Number | Z-1016-2024 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 8, 2024 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Becton Dickinson & Co. |
| Location | Sparks, MD |
| Product Type | Devices |
| Quantity | 2,363,168 total units |
Product Description
BD BBL Sensi Disc Aztreonam - 30 ug¿, used for semi-quantitative in vitro susceptibility testing. Catalog Numbers 231640¿and 231641.
Reason for Recall
There is a possibility of reproducibility, accuracy, and/or QC failures in antibiotic susceptibility testing (AST) for H. influenzae. This may cause product discard, delayed results, or additional adverse diagnostic outcomes, such as a delay in diagnosis, the selection of inappropriate antibiotics, or extended duration of antibiotic exposure and the treatment process.
Distribution Pattern
Domestic distribution nationwide. International distribution worldwide.
Lot / Code Information
Catalog No. 231640¿ UDI-DI 00382902316404 Lots 1117192 1211613 1243750 1278287 3214945; Catalog No. ¿231641 UDI-DI 30382902316412 Lots 2304491 3093375 3184116 3214945 3261101 3282901 1117192 1211613 1278287 1305148 2004458 2028924 2090502 2244457
Other Recalls from Becton Dickinson & Co.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0484-2026 | Class II | BD Kiestra" Isolate Suspension Cuvette Array; ... | Oct 23, 2025 |
| Z-0235-2026 | Class II | BD EpiCenter Microbiology Data Management Syste... | Sep 23, 2025 |
| Z-0236-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 2025 |
| Z-0240-2026 | Class II | BD Veritor Connect Software, labeled as the fol... | Sep 23, 2025 |
| Z-0237-2026 | Class II | BD BACTEC Blood Culture System, labeled as the ... | Sep 23, 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.