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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68592

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

Open FDA event record

Event summary

Timeline bucket
June 20, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
ORIGIO, 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

Name: Pasteur Pipets, used by the embryologist in the IVF Laboratory. Model numbers: PP-5.75-90 PP-9-90 PP-5.75-90PL PP-9-90PL

Z-1946-2014
Recall number
Z-1946-2014
Initiated
June 20, 2014
Classification
Class II
Status
Terminated
Recalling firm
ORIGIO, Inc
Quantity
Total number of Boxes Distributed 32,760. US 4,093 / Canada 1,156 / EU & Other 27,511

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
packaging breach of the nylon pouch sterile

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Identification of packaging breach of the nylon pouch sterile barrier for the 3-pack configuration

Code information

CODE: Model #s: PP-5.75-90, PP-9-90, PP-5.75-90PL, PP-9-90PL. Lots with labeled expiry date of May 2, 2015, or later.

Distribution pattern

Worldwide Distribution: US Nationwide, Canada, Australia, Barbados, Chile, China, Colombia, Denmark, Ecuador, France, Germany, Great Britain, Greece, India, Italy, Japan, Jordan, Malaysia, Netherlands, Peru, Russia, Singapore, South Africa, Spain, Taiwan, Turkey, and United Arab Emirates.

Field note

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