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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75890

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

Open FDA event record

Event summary

Timeline bucket
October 20, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Micromedics, 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

Nordson Micromedics FibriJet Endoscopic Catheter Introducer, Catalog Number SA-3445. Sterilized using Ethylene Oxide

Z-1817-2017
Recall number
Z-1817-2017
Initiated
October 20, 2016
Classification
Class II
Status
Terminated
Recalling firm
Micromedics, Inc.
Quantity
273 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
pouch, If the channels are present, the package integrity may be compromised
Sterility assurance reason.sterility_assurance · v1.0.0
package integrity may be compromised which may affect sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterile packaging may contain small channels in the seal of the pouch, If the channels are present, the package integrity may be compromised which may affect sterility assurance.

Code information

Lot Number: 163010 Expiration date: June 2021

Distribution pattern

AL, CA, FL, MS, NC, NJ, NY, TN, and TX. Outside the US: Israel