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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94087

1 recalled-product record grouped only because every row carries this exact official event ID.

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Event summary

Timeline bucket
February 21, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Puritan Medical Products Company, Llc

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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

Z-1391-2024
Recall number
Z-1391-2024
Initiated
February 21, 2024
Classification
Class II
Status
Ongoing
Quantity
465 boxes x 500 units per box = 232,500 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeled

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

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.

Code information

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

Distribution pattern

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.