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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79643

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

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Event summary

Timeline bucket
March 19, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical Europe Ltd

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

Teleflex MEDICAL LMA(TM) MADgic(TM) LARYNGO-TRACHEAL MUCOSAL ATOMIZATION DEVICE, MAD700, QTY: 1 Intended for the application of topical anesthetics to the oropharynx and upper airway region

Z-1628-2018
Recall number
Z-1628-2018
Initiated
March 19, 2018
Classification
Class II
Status
Terminated
Quantity
25 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

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

Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

Code information

Lot Number 161212

Distribution pattern

TX