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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68556

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

Open FDA event record

Event summary

Timeline bucket
March 25, 2014
Product types
Device
Classifications
Class I
Statuses
Terminated
Recalling firm wording
Wellspring Pharmaceutical Corporation

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

IPM Wound Gel Rx Wound Dressing IPM Wound Gel is indicated for the management of wound healing.

Z-2112-2014
Recall number
Z-2112-2014
Initiated
March 25, 2014
Classification
Class I
Status
Terminated
Quantity
3,135 cartons of 4/10g tubes

App-derived interpretation

Microbial contamination reason.microbial_contamination · v1.0.0
microbial contamination

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for microbial contamination of the product.

Code information

Lot #3P3446

Distribution pattern

Worldwide Distribution -- USA, including the states of Alabama, Arkansas, Georgia, Illinois, Kentucky, Louisiana, Missouri, Mississippi, New Jersey, South Carolina, Tennessee, Texas, and Virginia; and the country of Canada.