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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70633

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

Open FDA event record

Event summary

Timeline bucket
February 26, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Quest Medical, 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

LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.

Z-1368-2015
Recall number
Z-1368-2015
Initiated
February 26, 2015
Classification
Class II
Status
Terminated
Recalling firm
Quest Medical, Inc.
Quantity
106 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels

Code information

Lot 40905AQ and 40601C

Distribution pattern

Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.