FDAFDA · Food and drugs·Recall number Z-1391-2024
HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Published April 3, 2024 · Recall initiated: February 21, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Puritan Medical Products Company, Llc
- Distributor
- 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.
- Lot
- Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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