Affected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP).
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.
10885403233814, 07613203011853, 10885403226120, 10885403236112, 10885403229756, 10885403240997
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.