Z-2458-2021 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
- 630
Product Description
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E
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: 21015553