Exact FDA event identifier

Event 68681

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

Open FDA event record

Event summary

Timeline bucket: July 02, 2014
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Dynarex 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

CPR Shield With One Way Valve and Barrier Filter, Reorder No. 4921 --- Dynarex label, 100 per case --- Manufactured for: Dynarex Corporation - Made in China. Used as a physical barrier for mouth to mouth resuscitation.

Z-2117-2014

Recall number: Z-2117-2014
Initiated: July 02, 2014
Classification: Class II
Status: Terminated
Recalling firm: Dynarex Corporation
Quantity: Domestic: 208 cases; Foreign: 42 cases

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

wrong labeling

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.

Code information

Lot Numbers 28619 & 28621

Distribution pattern

Worldwide Distribution -- USA, Canada, and Mexico.