Exact FDA event identifier

Event 65869

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

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Event summary

Timeline bucket: July 08, 2013
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Sorin Group USA, 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

Edwards Lifesciences Suction Wand Model S099B, packaged in Sorin Group Heart/Lung Perfusion Packs.

Z-1985-2013

Recall number: Z-1985-2013
Initiated: July 08, 2013
Classification: Class II
Status: Terminated
Recalling firm: Sorin Group USA, Inc.
Quantity: 18,927 packs

App-derived interpretation

Foreign material or chemical contamination reason.foreign_material_chemical_contamination · v1.0.0

plastic particles

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Sorin Group is recalling certain lots of Edwards Lifesciences Suction Wand Model S099B due to presence of plastic particles inside the pouch.

Code information

Model S099B

Distribution pattern

Nationwide Distribution