BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check V...

FDA Device Recall #Z-2468-2021 — Class II — August 2, 2021

Recall Summary

Recall Number Z-2468-2021
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 295,331

Product Description

BD SmartSite Bag Access Device Needle-Free Valve, REF: 2300E; BD Bag access Device with 1 Check Valve And Needle Free Valve, REF: 2309E-0006

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: 20066502 20066503 20066504 20076251 20076352 20086483 20086484 20086485 20086486 20087129 20087130 20096280 20096281 20096282 20096283 20097163 20105074 20105075 20095374 20095375 20096302 20105754 20105755 20105756 20105757 20105758 20115470 21036462 21036463 21036464 21036465 21036466

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.