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FDA (Device enforcement)Recalled 2023-10-11class ii

Becton Dickinson & Company: BD Extension Sets (Product Name, Catalog #) BD SmartSite Filter Extension Set PE lined Standard bore 1 SmartSite bonded 0.2um Large PES Filter 1 PC RLL. L: 16 in PV: 4mL, C

Hazard

Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).

Details from the source

Reason for recall: Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). Distribution: Worldwide - US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WI, WY, Puerto Rico, Guam; and the countries of Australia, Brazil, Canada, Dominican Republic, India, Kuwait, Mexico, New Zealand, Philipp Quantity: N/A Lot/code info: UDI-DI: 10885403233814, Catalog # 10013902 UDI-DI: 07613203011853, Catalog # 20062E; UDI-DI: 10885403226120, Catalog # 70000N-07; UDI-DI: 10885403236112, Catalog # ME1224; UDI-DI: 10885403229756, Catalog # 20350ET; UDI-DI: 10885403240997, Catalog # 70001B-07T. All lots, thru expiration date October 16, 2026.

UPC codes

10885403233814, 07613203011853, 10885403226120, 10885403236112, 10885403229756, 10885403240997

Source

Official record: FDA (Device enforcement)

Republished from the official source above; details can change — the source record controls.

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