Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77469

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

Open FDA event record

Event summary

Timeline bucket
June 02, 2017
Product types
Device
Classifications
Class III
Statuses
Ongoing
Recalling firm wording
C.R. Bard, 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

Arctic Sun ArcticGel Pads - Medium, Product Code 317-07

Z-0590-2018
Recall number
Z-0590-2018
Initiated
June 02, 2017
Classification
Class III
Status
Ongoing
Recalling firm
C.R. Bard, Inc.
Quantity
128 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Label on product box contains the incorrect

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

Label on product box contains the incorrect reference #317-09 while the shelf box label with barcode and the internal foil pouch label are correctly labeled with product code 317-07 and lot number NDAR0462.

Code information

Product code 317-07, Lot Number NGAR0462, Device Listing Number D234021.

Distribution pattern

Distributed domestically. Distributed internationally to Australia and Belgium.

Field note

Send feedback

We'll only use this to respond to your feedback.