Exact FDA event identifier

Event 75428

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

Open FDA event record

Event summary

Timeline bucket: October 12, 2016
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: C.R. Bard, 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

C-Max" Cutting Loop Electrodes, Storz One-Stem, 24 Fr, .014in., .35 mm, Sterile, Rx only, Manufactured by: C.R. Bard, Inc., Covington, GA 30014.

Z-0585-2017

Recall number: Z-0585-2017
Initiated: October 12, 2016
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 70 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Other

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Defect; The contact part could possibly separate from the electrode affecting to functionality of the device.

Code information

Product Code: 355325, Lot Numbers: NGAQ5248 and NGAN2854

Distribution pattern

FL, GA, LA, OH, VA and WA.