Z-1391-2024Class II

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

Name: Z-1391-2024 HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H
Creator: Puritan Medical Products Company, Llc
Published: 2024-02-21
License: https://open.fda.gov/license/

Puritan Medical Products Company, LLC / initiated 2024-02-21 / Open, Classified / root cause: manufacturing process

FDA source

Puritan Medical Products Company, Llc began a recall of HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H on 2024-02-21. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1391-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-21
Posted: 2024-03-28
Recalling firm: Puritan Medical Products Company, LLC
Product: HydroFlock Sterile Flocked Collection Device, Part Number 25-3317-H.
Product code: KXG Applicator, Absorbent Tipped, Sterile
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: URGENT: FIELD SAFETY NOTICE/MEDICAL DEVICE RECALL letters were sent to customers 21-Feb-2024. Customers were instructed to: 1. Carefully read the content of this notification. 2. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of this notification. 3. Document on the Reply Form the number of the affected products currently located at your facility and confirm they have been destroyed. 4. If you have already further processed or utilized this product in a kit, assess the impact of the incorrect collection device on the final medical device / in vitro diagnostic that is distributed. 5. Notify your customers of this field action. Advise your customers to cease use or further distribution of the affected product, destroy kits containing this affected product, and re-review any results already obtained using these collection devices. Please appropriately document your notification process and let us know the end-customer feedback accordingly. 6. Attest that and that you have received and understood this notification and have notified any additional customers you may have distributed to by filling out and returning the completed enclosed Reply Form by 27-Feb-2024. Puritan Medical is coordinating with the applicable Regulatory Agencies. We fully appreciate your prompt cooperation in addressing this situation and working with us to ensure your patients are treated only with safe and effective Puritan products that you have come to rely upon. If you require additional information or on-site support, please do not hesitate to contact Puritan directly at (800) 321-2313 from Monday through Friday or by e-mail at [email protected].
Quantity in commerce: 465 boxes x 500 units per box = 232,500 units
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.
Product codes and lots: Part number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1391-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1391-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-03	2024-03-28

Product code KXG

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)