PlainRecalls
FDA Devices Moderate Class II Ongoing

BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E

Reported: September 22, 2021 Initiated: August 2, 2021 #Z-2458-2021

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.

Details

Recalling Firm
CAREFUSION
Units Affected
630
Distribution
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.
Location
San Diego, CA

Frequently Asked Questions

What product was recalled?
BD BURETTE GRAVITY SET 60 DROP 2 Smartsite VALVES VENTED/NONVENTED, REF: 42163E. Recalled by CAREFUSION. Units affected: 630.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on September 22, 2021. Severity: Moderate. Recall number: Z-2458-2021.