CAREFUSION recalls BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-…

Recall date

August 2, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2463-2021

FDA classification

Class II

Brand / firm

CAREFUSION

Sold / distributed

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 o…

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

BD Gravity IV Set 3-port Closed Manifold Back Check Valve 3 Needle-Free Y-sites, REF: CM42500E-07; BD Gravity IV Set 3-port Closed Stopock Manifold Back Check Valve 2 Needle-Free Y-sites, REF: CS42522E-07; BD GRAVITY 10 DP V/NV CHECK VALVE 3-WAY STOPCOCK 4 Smartsite VALVES & SmartSite EXT SET, REF: 42407E-05