PlainRecalls
FDA Devices Moderate Class II Ongoing

BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER V

Reported: September 22, 2021 Initiated: August 2, 2021 #Z-2456-2021

Product Description

BD Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER VENTED/NONVENTED, REF: 82115E

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
77,802
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 Gravity Burette Set 60 DROP 1.2 MF 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV, REF: 10037031; BD Gravity Burette Set 20 DROP 1.2 Micron Filter 2 SmartSite VALVES BALL VALVE DRIP CHAMBER V/NV , REF: 10037032; BD GRAVITY BURETTE SET 60 DROP 2 Smartsite VALVES BALL DRIP CHAMBER \VENTED/NONVENTED, REF: 82104E; BD ADD-ON BURETTE SET Smartsite VALVE, REF: 82113E; BD ADD-ON BURETTE SET Smartsite VALVE VENTED/NONVENTED, REF: 82114E; BD ADD-ON BURETTE SET Smartsite VALVE BALL VALVE DRIP CHAMBER VENTED/NONVENTED, REF: 82115E. Recalled by CAREFUSION. Units affected: 77,802.
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-2456-2021.

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