Puritan Medical Products Company, Llc: Medical Device Recall in 2024 - (Recall #: Z-1391-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: February 21, 2024

Date Posted: April 3, 2024

Recall Number: Z-1391-2024

Event ID: 94087

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.

Status: Ongoing

Product Quantity: 465 boxes x 500 units per box = 232,500 units

Code Information:

Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated