# FDA recall Z-1391-2024

> **Puritan Medical Products Company, Llc** · Class II · device recall initiated 2024-02-21.

## 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

- **Recall number:** Z-1391-2024
- **Recalling firm:** Puritan Medical Products Company, Llc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-02-21
- **Report date:** 2024-04-03

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Guilford, ME, United States

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-1391-2024. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1391-2024. Source: US FDA. Licensed CC0.

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