FDA recall Z-1391-2024

Product

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

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.

Key facts

Status

Ongoing

Initiation date

2024-02-21

Report date

2024-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guilford, ME, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1391-2024