Product Safety Recalls

Product Recall Tracker

CAREFUSION Recall 88203

Description: BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D

CAREFUSION Recall 88203 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-2467-2021
Event ID88203
Event DescriptionBD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Luer, REF: 20037E7D; BD SmartSite Extension Set 3 Needle Free Valves, REF: 20038E7D; BD SmartSite Extension Set One Needle Free Valve, REF: 20039E7D; BD SmartSite Extension Set 1 Needle-Free Valve, 20049E7D; BD Extension Set 1 Needle-Free Valve, REF: 20059E-0006; BD SmartSite Extension Set 1 Needle-Free Valve, REF: 20060E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20061E7D; BD SmartSite Extension Set Check Valve 3 Needle Free Valves, REF: 20062E7D; BD SmartSite Extension Set 2 Needle Free Valves, REF: 20159E7D; BD Alaris GP Series SmartSite Burette Set, REF: 60103E; BD Alaris GP Series Burette Set No Filter, REF: 63441E; Alaris SmartSite needle-free valve, REF: 2000E7D
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.
Quantity23,786,178
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: 20025240 20025241 20025242 20056225 20056231 20056229 20056230 21025820 21025823 21025824 21025825 21025829 20036690 20036691 20036692 20036694 20036983 20046920 20046921 20046922 20055220 20055221 20055222 20055223 20055379 20055380 20055381 20055382 20055503 20055504 20055505 20055506 20055507 20055508 20055880 20055881 20055882 20055883 20055884 20055885 20055886 20055887 20055888 20055889 20055890 20065100 20065101 20065102 20065104 20065103 20065105 20065106 20065107 20065108 20065109 20065110 20065111 20065986 20065987 20065988 20065989 20066898 20066936 20066937 20066938 20066939 20066940 20067172 20075176 20075177 20075481 20075482 20075623 20075483 20075484 20075624 20075625 20075793 20075794 20076070 20076071 20076486 20076487 20076488 20076489 20076490 20076491 20076576 20076577 20076578 20076686 20076687 20076769 20076770 20076771 20076772 20076773 20076774 20077355 20077356 20077357 20077358 20077359 20077360 20077361 20077362 20077363 20077364 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Center Classification Date20210913
Recall Initiation Date20210802
Recalling FirmCAREFUSION
Initial Notification Letter
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