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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 81095

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

Open FDA event record

Event summary

Timeline bucket
September 06, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
CryoLife, 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

CryoPatch SG Pulmonary Hemi-Artery, 1 graft

Z-0121-2019
Recall number
Z-0121-2019
Initiated
September 06, 2018
Classification
Class II
Status
Terminated
Recalling firm
CryoLife, Inc.
Quantity
1 graft

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The conduit length and branch length of a SG Pulmonary Hemi-Artery were switched on the product labeling. The graft labeling indicates the conduit length is 1.0cm and the branch length is 4.5cm.

Code information

Model Number SGPH00, Serial Number 10978889, Lot Number 144125, Expiration Date 05/16/2022

Distribution pattern

US Nationwide in the state of California.