BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE...
FDA Device Recall #Z-2461-2021 — Class II — August 2, 2021
Recall Summary
| Recall Number | Z-2461-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | August 2, 2021 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | CAREFUSION |
| Location | San Diego, CA |
| Product Type | Devices |
| Quantity | 708,910 |
Product Description
BD SmartSite Bag Access Device, REF: 2300E-0500; BD BAG ACCESS DEVICE CHECK VALVE SmartSite VALVE, REF: 2309E
Reason for Recall
Needle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and partial or total occlusions, which could lead to therapy delay. Follow-up activates not required if product has already been used or was safely connected to the female luer of connecting device.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of FL, PA, NC, OH, SC, IL, RI, MO, NY, TN, AL, VA, PR, CA, NE, NJ, MI, MD, NM, LA, KY, NV, ME, OK, WA, MA, WV, TX, AR, OR, KS, GA, VT, IN, WY, AZ, CO, MN, WI, UT, SD, MS, ID, MT, ND, HI, IA, DC, AK, NH, CT, DE, GU and the countries of CA, NZ, TW, AU, BE, VN, AR, MY, TH, KR, ID, PH, SG, BH, SA, HK, IN, CN, BR.
Lot / Code Information
Lots: 20025450 20025451 20025452 20025531 20025532 20025533 20025534 20026527 20026529 20026532 20026533 20026534 20065580 20065582 20065581 20075239 20075240 20075241 20075242 20075618 20075619 20075447 20075448 20075449 20075450 20075451 20075452 20075453 20075790 20075791 20075924 20075792 20085362 20085363 20085364 20085365 20085421 20085422 20085522 20085523 20095302 20095303 20095310 20095533 20095534 20095311 20095312 20116500 20116501 21016470 21016471 21016593 20035697 20066252 20066399 20076260 20095373 20095887 20105859 20105860 20105861 20106710 21019903 21019904 21019905
Other Recalls from CAREFUSION
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1756-2022 | Class II | BD MaxGuard Drop Administration set with 3 Need... | Aug 1, 2022 |
| Z-1760-2022 | Class II | BD MaxGuard 15 Drop Administration Set with 4 N... | Aug 1, 2022 |
| Z-1754-2022 | Class II | BD MaxGuard Flow Controller Extension Set with ... | Aug 1, 2022 |
| Z-1755-2022 | Class II | BD MaxGuard Flow Controller Extension Set with ... | Aug 1, 2022 |
| Z-1753-2022 | Class II | BD MaxGuard Extension Set, REF: ME1069 | Aug 1, 2022 |
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.