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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 92124

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

Open FDA event record

Event summary

Timeline bucket
March 03, 2023
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Access Vascular, Inc

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

HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004

Z-1605-2023
Recall number
Z-1605-2023
Initiated
March 03, 2023
Classification
Class II
Status
Ongoing
Recalling firm
Access Vascular, Inc
Quantity
240 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The catheter packaged with specific lots of the HydroPICC Kits and HydroMID Kits have a shorter expiration date than what is listed on the outer kit package.

Code information

UDI-DI: 00862559000487; Lot Number: 11423949

Distribution pattern

US distribution to States of: FL, TN, TX.

Field note

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