Puritan Medical Products Company, Llc: HydroFlock Collection Devices Recalled for Mislabeling and Incorrect Product

Agency Publication Date: March 28, 2024

Summary

Puritan Medical Products is recalling 465 boxes (approximately 232,500 units) of HydroFlock Sterile Flocked Collection Devices because the packages are mislabeled. Boxes marked as part number 25-3317-H actually contain a different product, part number 25-3317-U. This defect was discovered through a customer complaint, and the products were distributed worldwide, including 20 U.S. states.

Risk

Using an incorrect medical collection device can lead to improper specimen collection, potential diagnostic errors, or incompatible use with specific clinical protocols. While no injuries have been reported, the presence of the wrong device in sterile packaging poses a clinical risk to patients and healthcare providers.

What You Should Do

Identify your product by checking the outer packaging for part number 25-3317-H and Lot Number S1014.
Check the individual package codes inside the box; if the internal product code is 25-3317-U, it is affected by this recall.
Stop using the mislabeled product immediately and set it aside to ensure it is not used in clinical procedures.
Contact Puritan Medical Products Company, Llc for instructions on how to return or replace the affected devices.
Contact your healthcare provider or clinic administrator if you have concerns about previous uses of these devices.
For further information or questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

Manufacturer Notification

How to: Puritan notified customers via letter. Contact your healthcare provider or the manufacturer for further instructions and potential refund.

Affected Products

Product: HydroFlock Sterile Flocked Collection Device (500 units per box)

Model / REF:

25-3317-H

25-3317-U

UPC Codes:

00609576330322

Lot Numbers:

S1014

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 94087

Status: Active

Manufacturer: Puritan Medical Products Company, Llc

Sold By: Puritan Medical Products Company, Llc; Worldwide distribution

Manufactured In: United States

Units Affected: 465 boxes x 500 units per box = 232,500 units

Distributed To: Alabama, California, Florida, Georgia, Iowa, Idaho, Illinois, Indiana, Kentucky, Massachusetts, Michigan, Missouri, North Carolina, New Jersey, New York, Ohio, Oklahoma, Pennsylvania, Texas, Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

Identify your product by checking the outer packaging for part number 25-3317-H and Lot Number S1014.

Check the individual package codes inside the box; if the internal product code is 25-3317-U, it is affected by this recall.

Stop using the mislabeled product immediately and set it aside to ensure it is not used in clinical procedures.

Contact Puritan Medical Products Company, Llc for instructions on how to return or replace the affected devices.

Contact your healthcare provider or clinic administrator if you have concerns about previous uses of these devices.

For further information or questions, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.