Medical Device Recall: HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Puritan Medical Products Company, Llc · February 21, 2024
Reason for Recall
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.
Distribution
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.
States Affected
NATIONWIDE
Quantity Affected
465 boxes x 500 units per box = 232,500 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1391-2024
Status: ongoing
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