BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037...

FDA Device Recall #Z-2456-2021 — Class II — August 2, 2021

Recall Summary

Recall Number Z-2456-2021
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 77,802

Product Description

BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER VENTED/NONVENTED, REF: 82115E

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: 20065590 20065591 20075066 20105945 20105946 20105947 20106408 21015533 21015552 20106612 20115540 21046676 20096121 20115539 21025938 21025939 21025940 21025941 21035175 21035176 20066404 21035174 20096120 20106171 20106172 20106173 20106174 20106175

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.