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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70666

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

Open FDA event record

Event summary

Timeline bucket
January 30, 2015
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

Bard 100% Latex-Free Urinary Drainage Bag with Anti-Reflux Chamber and Bard EX-Lok Sampling; Product Code 154006: Lot # NGYJ0603 and NGYJ1671

Z-1358-2015
Recall number
Z-1358-2015
Initiated
January 30, 2015
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard, Inc.
Quantity
9,620 units

App-derived interpretation

Sterility assurance reason.sterility_assurance · v1.0.0
breach of the sterile barrier

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential breach of the sterile barrier packaging.

Code information

Lot Numbers NGYJ0603 and NGYJ1671

Distribution pattern

Nationwide Distribution to the states of : AL, AZ, CA, FL, GA, IL, IN, KY, LA, MD, MA, MI, MN, MS, MO, NJ, NY, NC, OH, OK, OR, PA, RI, SC, TN, TX, VA, WV and WA.