FDA-Device2021-09-22Class II
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2M
CAREFUSION
Hazard
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.
Sold states
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.
Affected count
344,300
Manufactured in
10020 Pacific Mesa Blvd, N/A, San Diego, CA, United States
Products
BD Alaris Pump Infusion Buerette Set 0.2 Micron Filter Smallbore Tubing SmartSite Port (Burette) SmartSite Y-Site, REF: 10015012; BD Alaris Pump Infusion Buerette Set Ball Valve Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 10817920; BD Alaris Pump Infusion Buerette Set SmartSite Port (Burette) 3 SmartSite Y-Sites, REF: 10821753; BD Alaris Pump Infusion Buerette Smallbore Tubing Smartsite Port (Burette) SmartSite Y-Site, REF: 11607787; BD Alaris Pump Infusion Buerette Set 0.2Micron Filter Ball Valve SmartSite Port (Burette) 2 SmartSite Y-Sites, REF: 11613191; BD Alaris Pump Infusion Buerette Set Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2440-0600; BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Site, REF: 2441-0007; BD Alaris Pump Infusion Buerette Set Low Sorbing Tubing Smartsite Port (Burette), REF: 2444-0007; BD Alaris Pump Infusion Buerette Set Ball Valve Smartsite Port (Burette) 2 Smartsite Y-Sites, REF: 2447-0007; BD Alaris Pump Infusion Set Back Check Valve 4-Way Stopcock 3 Smartsite Y-Sites Extension Set With SmartSite Port, REF: C24104E
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2459-2021Don't want to check this manually?
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