Exact FDA event identifier

Event 81150

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: August 22, 2018
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Safe N Simple, 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

2 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 2

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING, 4" X 5", 10 Pads, Catalogue number SNS58315

Z-0400-2019

Recall number: Z-0400-2019
Initiated: August 22, 2018
Classification: Class II
Status: Terminated
Recalling firm: Safe N Simple, LLC
Quantity: 104 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The sterilization process used was unqualified.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterilization process used was unqualified.

Code information

lot number 18060563

Distribution pattern

device · product 2 of 2

Simpurity HYDROGEL ABSORBENT SHEET WOUND DRESSING ADHESIVE BORDER, 4" X 5", 12 Pads, Catalogue number SNS58345

Z-0401-2019

Recall number: Z-0401-2019
Initiated: August 22, 2018
Classification: Class II
Status: Terminated
Recalling firm: Safe N Simple, LLC
Quantity: 125 cases

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The sterilization process used was unqualified.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The sterilization process used was unqualified.

Code information

lot number 18060564