Exact FDA event identifier

Event 74368

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

Open FDA event record

Event summary

Timeline bucket: June 08, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Amd-Ritmed, 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

AMD-Ritmed Transparent Dressing - Window with label, 4 " x 4 3/4" (10 cm x 12 cm), Reorder No./Code A60044-W, Sterile -- 200 Dressings per case -- Made in China for AMD-Ritmed Inc. 1200 55th Ave., Lachine, QC H8T 3J8/295 Firetower Road, Tonawanda, NY 14150

Z-0727-2017

Recall number: Z-0727-2017
Initiated: June 08, 2016
Classification: Class II
Status: Terminated
Recalling firm: Amd-Ritmed, Inc.
Quantity: US: 216 cases (200 dressings per case)

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Material/Component Contamination

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The lot of transparent dressing was found to be contaminated (not sterile) based on FDA sampling and analysis.

Code information

Lot 68408, expiration date 2018¿05

Distribution pattern

NY, MA, VA, TN