Product Safety Recalls

Product Recall Tracker

CAREFUSION Recall 88203

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

CAREFUSION Recall 88203 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2456-2021
Event ID88203
Event DescriptionBD 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
Product TypeDevices
DistributionWorldwide 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.
Quantity77,802
Recall ReasonNeedle-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.
Device Classification20210922
Device Code InfoLots: 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
Center Classification Date20210913
Recall Initiation Date20210802
Recalling FirmCAREFUSION
Initial Notification Letter
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