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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 79536

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

Open FDA event record

Event summary

Timeline bucket
January 03, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
GETINGE US SALES LLC

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

HEMASHIELD Knitted Double Velour Cardiovascular Fabric

Z-1172-2018
Recall number
Z-1172-2018
Initiated
January 03, 2018
Classification
Class II
Status
Terminated
Recalling firm
GETINGE US SALES LLC
Quantity
1

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
mislabeling

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

A probable mislabeling of the product: a different-sized product is referenced on the product packaging label (i.e. 2.5 cm (width) x 7.6 cm (length)) while the actual product inside the box is 2.5 cm (width) x 15 cm (length).

Code information

UDI code: 00384401017899 Catalog number: M002000195140 Lot number: 16M21 Serial number: 1092238229

Distribution pattern

FL