Exact FDA event identifier

Event 72922

3 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: December 18, 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

3 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 3

BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Z-1357-2016

Recall number: Z-1357-2016
Initiated: December 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 1,428,000 units (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling error

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

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Code information

Catalog numbers: 0165I108 and 065SI10; All lot numbers produced with IFU (PK7634040) are affected.

Distribution pattern

Distributed US (nationwide) and the countries of Canada and Australia.

device · product 2 of 3

BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Z-1358-2016

Recall number: Z-1358-2016
Initiated: December 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 1,428,000 units (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling error

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

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Code information

Code(s): Catalog numbers: 01655SI12, 01655SI14, 01655SI16, 01655SI18, 01655SI20, 01655SI22, 01655SI24, 01655SI26, 01655SI28 and 01655SI30. All lot numbers produced with IFU (PK7634040) are affected.

Distribution pattern

Distributed US (nationwide) and the countries of Canada and Australia.

device · product 3 of 3

BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model); Intended for urinary bladder drainage in female patients requiring catheterization for management of incontinence, voiding dysfunction and surgical procedure.

Z-1359-2016

Recall number: Z-1359-2016
Initiated: December 18, 2015
Classification: Class II
Status: Terminated
Recalling firm: C.R. Bard, Inc.
Quantity: 1,428,000 units (total)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0

Labeling error

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

Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume.

Code information

CodeCatalog numbers: 0146SI16, 0146SI18, 0146SI20 and 0146SI22. All lot numbers produced with IFU (PK7634040) are affected.

Distribution pattern

Distributed US (nationwide) and the countries of Canada and Australia.