Exact FDA event identifier

Event 74249

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

Open FDA event record

Event summary

Timeline bucket: May 20, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Amerx Health Care Corp.

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

Amerigel Hydrogel Wound Dressing Advanced Formula for wound management 1 oz.

Z-2249-2016

Recall number: Z-2249-2016
Initiated: May 20, 2016
Classification: Class II
Status: Terminated
Recalling firm: Amerx Health Care Corp.
Quantity: 6,993 Units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Product did not meet specifications for Zinc Acetate (OOS).

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product did not meet specifications for Zinc Acetate (OOS).

Code information

Lot # 668

Distribution pattern

AR, AZ, CA, CO, CT, FL, GA, IL, IN, MA, MD, MI, MO, NC, NJ, NM, NY, OH, OK, OR, PA, SC, TN, TX, VA, & Alaska. Bahrain & Colombia.