Exact FDA event identifier

Event 65734

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

Open FDA event record

Event summary

Timeline bucket: November 21, 2012
Product types: Device
Classifications: Class III
Statuses: Terminated
Recalling firm wording: Remel 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

Oxoid Antimicrobial Susceptibility Test Discs, CTO425B Ciprofloxacin CIP 5 mcg, 50 discs per cartridge, 5 cartridges per box. The firm name on the box label is Oxoid Ltd., Basingstoke, UK. Used in the semi-quantitative agar diffusion test method for in vitro susceptibility testing to assist in the determination of a suitable antibiotic agent for treatment purposes.

Z-0528-2014

Recall number: Z-0528-2014
Initiated: November 21, 2012
Classification: Class III
Status: Terminated
Recalling firm: Remel Inc
Quantity: 60/5/50-disc cartridge boxes

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Boxes labeled as CIP5 may contain cartridges of AMP5.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Boxes labeled as CIP5 may contain cartridges of AMP5.

Code information

Lot number: 1220205, exp July 21, 2015

Distribution pattern

Nationwide Distribution including AL, CA, CO, FL, IA, KS, LA, MA, MS, NE, NH, NJ, NY, OK, OR, RI, TN, TX, VA, WA WI, and Puerto Rico.