Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

HydroFlock Sterile Flocked Collection Device Recalled by Puritan Medical Products Company, Llc Due to Mislabeling

Date: February 21, 2024
Company: Puritan Medical Products Company, Llc
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Puritan Medical Products Company, Llc directly.

Affected Products

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

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

Why Was This 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.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Puritan Medical Products Company, Llc

Puritan Medical Products Company, Llc has 1 total recall tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report