Exact FDA event identifier

Event 77369

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

Open FDA event record

Event summary

Timeline bucket: May 19, 2017
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

BioGlue Surgical Adhesive, Model/Catalog Number BG3510-5-J

Z-2623-2017

Recall number: Z-2623-2017
Initiated: May 19, 2017
Classification: Class II
Status: Terminated
Recalling firm: CryoLife, Inc.
Quantity: 705 single pack boxes

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

incorrectly labeled

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 courtesy labels in 9 boxes of BioGlue were incorrectly labeled as lot 17MJX007 instead of lot 17MJX002.

Code information

Lot Code 17MJX002, Model/Catalog Number BG3510-5-J

Distribution pattern

Product distributed in Japan.