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Puritan Medical Products Company, Llc recalls HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Recalled April 3, 2024 · FDA recall Z-1391-2024 · Puritan Medical Products
Hazard
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages. · FDA Class II
Units
465 boxes x 500 units per box = 232,500 units
Sold at
Worldwide - US Nationwide distribution in the states of AL, CA, FL, GA, IA, ID, IL, IN, KY, MA, MI, MO, NC, NJ, NY, OH, OK, PA, TX, VA and the countries of Canada, P.R. China and Thailand.
Description
It was discovered through a customer complaint that mislabeled product was distributed. Puritan distributed product labelled as 25-3317-H lot S1014 which contained product code 25-3317-U in all packages.
Product
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Manufacturer(s)
Puritan Medical Products Company, Llc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →