Home / Recalls / CAREFUSION / Z-2466-2021

Z-2466-2021 Class II Ongoing

Recalled by CAREFUSION — San Diego, CA

FDA device recall Z-2466-2021 was initiated by CAREFUSION on August 2, 2021 and is designated Class II. 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 … The recall status is ongoing. Affected quantity: 270.

Recall Details

Product Type: Devices
Report Date: September 22, 2021
Initiation Date: August 2, 2021
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 270

Product Description

BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006

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.

Code Information

Lots: 20077170 20077171 20077319 20077320

Other recalls by CAREFUSION

Z-1755-2022 Class II — BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 (August 1, 2022)
Z-1753-2022 Class II — BD MaxGuard Extension Set, REF: ME1069 (August 1, 2022)
Z-1759-2022 Class II — BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9 (August 1, 2022)
Z-1760-2022 Class II — BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 (August 1, 2022)
Z-1752-2022 Class II — BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 (August 1, 2022)
Z-1756-2022 Class II — BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port M (August 1, 2022)
Z-1758-2022 Class II — BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9 (August 1, 2022)
Z-1754-2022 Class II — BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 (August 1, 2022)
Z-1757-2022 Class II — BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 (August 1, 2022)
Z-2460-2021 Class II — BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite (August 2, 2021)