Exact FDA event identifier

Event 76775

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

Open FDA event record

Event summary

Timeline bucket: March 09, 2017
Product types: Device
Classifications: Class II
Statuses: Completed
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

SURESTEP Tray, Bardex I.C. Complete Care Drainage Bag, 2000 ml Drainage Bag, 16 Fr., Sterile.

Z-1871-2017

Recall number: Z-1871-2017
Initiated: March 09, 2017
Classification: Class II
Status: Completed
Recalling firm: C.R. Bard, Inc.
Quantity: 5030 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Misbranded

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

Misbranded: Product labeled, Not made with natural rubber latex, may in fact contain natural rubber latex.

Code information

Product Code: A300316A, Lot number: NGAV2400

Distribution pattern

CA, CO, FL, GA, IA, IL, IN, KY, LA, MI, MN, MS, NC, NE, NJ, NM, OH, OR, PA, RI, TN, TX, VA and WA.