HydroFlock Sterile Flocked Collection Device recalled over labeling errors

Recall date

February 21, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Puritan Medical Products Company, Llc recalls HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.

Recall number

Z-1391-2024

FDA classification

Class II

Brand / firm

Puritan Medical Products Company, Llc

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.