Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69368

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

Open FDA event record

Event summary

Timeline bucket
September 18, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
KCI USA, 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

V.A.C. GranuFoam Silver Large Dressing is barrier to bacterial penetration and may help reduce infection. Featuring SensaT.R.A.C. Technology REF M8275099/10 STERILE Single Use only Latex Free Rx Only.

Z-0070-2015
Recall number
Z-0070-2015
Initiated
September 18, 2014
Classification
Class II
Status
Terminated
Recalling firm
KCI USA, Inc.
Quantity
1090 pouches (109 boxes)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A portion of the V.A.C. GranuFoam Silver Dressing M8275099/10 lot 50775977 was incorrectly manufactured with an incorrect expiry date on the sterile pouch. The correct expiry date of 2015-11 is on the case label, however the pouch label identifies the expiry date of 2016-11.

Code information

Lot Number 50775911

Distribution pattern

The affected product was distributed to Mexico, Turkey, and United Arab Emirates only. The affected product was not distributed to the US.