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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72780

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

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Event summary

Timeline bucket
December 01, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
3M Company - Health Care Business

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

3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.

Z-0601-2016
Recall number
Z-0601-2016
Initiated
December 01, 2015
Classification
Class II
Status
Terminated
Quantity
167 cases (30 rolls/case)

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

Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.

Code information

Catalog# 1581, lot # 2020-10AN Catalog# 2081, lot # 2018-AM (shipper carton)

Distribution pattern

US nationwide distribution.