CLASS II ONGOING Device recall · Reported 3 Apr 2024 · FDA Enforcement Report

HydroFlock Sterile Flocked Collection Device recalled

Puritan Medical Products Company is recalling HydroFlock Sterile Flocked Collection Device, distributed nationwide in the US. The recall was initiated on 21 Feb 2024 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesPart number: 25-3317-H; UDI/DI: 00609576330322; Serial/Lot Number: S1014;

Quantity recalled465 boxes x 500 units per box = 232,500 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1391-2024
FDA event ID: 94087
Recalling firm: Puritan Medical Products Company, Guilford, ME
Classification: Class II
Status: Ongoing
Recall initiated: 21 Feb 2024
FDA classified: 28 Mar 2024
Reported: 3 Apr 2024
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Other Medical Devices

Timeline

21 Feb 2024	Recall initiated by company
28 Mar 2024	Classified by FDA	+36 days
3 Apr 2024	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Product as listed by the FDA

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

Where it was distributed

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.

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

Questions about this recall

Why was it recalled?

Which lots are affected?

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

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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