Z-2464-2021 Class II Ongoing
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
- 44,120
Product Description
BD ADD-ON Burette Set V/NV Needle-Free Valve, REF: 82113E-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: 20066405 20075901 20075902 20076376 20076377 20116469 21016457 21016458 21016459 21016460 21016690 21016691 21035305 21035306 21035418 21035419 21035420 21035421 21035422 21035423 21035424