FDA recall Z-0350-2024

Becton Dickinson & Company · Class II · device

Product

BD gravity sets (Product Name, Catalog #) 32-IN GRAV SET W/0.2 MICRON FILTER BAG ACCESS PORT SS VALVE TEXIUMTM LOW ABSORPTION, Catalog # 4030B-07T and BD GRAVITY BLOOD SET 15 DROP 180 MICRON FILTER SmartSiteTM VALVE NONVENTED, Catalog # 42081E.

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, Philippines, Poland, Saudi Arabia, Singapore, Taiwan, United Arab Emirates.

Key facts

Status
Ongoing
Initiation date
2023-10-11
Report date
2023-11-29
Voluntary/Mandated
Voluntary: Firm initiated
Location
Franklin Lakes, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0350-2024