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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78664

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

Open FDA event record

Event summary

Timeline bucket
October 16, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
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

Medivance ArcticGel Small Pad Kit - a box containing a single foil pouch, which contains a set of four (4) pads. A set of pads comprise a left and a right torso pad, and a left and a right thigh pad. Is a Thermal regulating system, indicated for monitoring and controlling patient temperature in adult and pediatric patients of all ages.¿

Z-0271-2018
Recall number
Z-0271-2018
Initiated
October 16, 2017
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard, Inc.
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Hydrogel peeling from the pads.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Equipment maintenance

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Hydrogel peeling from the pads.

Code information

Product Code: 31705 Lot # NGBS1063

Distribution pattern

US Distribution to the states of : FL, LA, IL, CA, MO, MN, TX, OK, TN, and NY