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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75273

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

Open FDA event record

Event summary

Timeline bucket
September 24, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Surgical Specialties Mexico S DE RL DE CV

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

BioSentry Tract Sealant System, Product Code: 768022019S; Indicated to provide accuracy in marking a biopsy location for visualization during surgical resection.

Z-0068-2017
Recall number
Z-0068-2017
Initiated
September 24, 2016
Classification
Class II
Status
Terminated
Quantity
512 boxes (2560 units)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
open seal

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

Surgical Specialties Mexico is recalling the BioSentry Track Sealant System due to the potential for an open seal on the product package.

Code information

MAWX380, MAZD460, MAZR350, MBCF540

Distribution pattern

US: OH, PA, CO, MA, DE, CA, NY, VA, WA, NJ, CT, FL, TX, NH, ID, OK, AZ, GA, PA, NV, VT. Worldwide: Spain, Italy, United Kingdom, Portugal, Turkey, Germany, Denmark,

Field note

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