Exact FDA event identifier

Event 77281

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

Open FDA event record

Event summary

Timeline bucket: August 08, 2016
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Acumedia Manufacturers, 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

Sabouraud Dextrose Agar w /Lecithin and Tween 20 Acumedia PN 91081 Product Usage: Used for the isolation of fungi from surfaces sanitized with quaternary ammonium compounds

Z-2212-2017

Recall number: Z-2212-2017
Initiated: August 08, 2016
Classification: Class III
Status: Terminated
Recalling firm: Acumedia Manufacturers, Inc.
Quantity: 10 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

label was incorrect

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Storage temperature listed on the label was incorrect. Label stated 2-30¿C. Actual storage temperature is 2-8¿C.

Code information

PN 91081C, Lot 108367A PN 91081C, Lot 107632A

Distribution pattern

US in the state of IL