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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 94394

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

Open FDA event record

Event summary

Timeline bucket
April 02, 2024
Product types
Device
Classifications
Class II
Statuses
Ongoing
Recalling firm wording
Andover Healthcare 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

Sterile CoFlex NL: Latex Free Flexible Cohesive Bandage, Tan, 4INx5YD (5400S)

Z-1828-2024
Recall number
Z-1828-2024
Initiated
April 02, 2024
Classification
Class II
Status
Ongoing
Recalling firm
Andover Healthcare Inc.
Quantity
108 cases (1,944 individual product packages)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A packaging seal gap could impact the sterility of the product.

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

A packaging seal gap could impact the sterility of the product.

Code information

Model Number: 5400S; UDI/DI: 10724004641072; Batch 0031151359, Lot 10009897233.

Distribution pattern

US Nationwide distribution in the states of CA, CO, GA, IA, IN, OH, MN, NC, PA, TX, VA, WA.