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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 75469

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

Open FDA event record

Event summary

Timeline bucket
August 03, 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

4 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 4

BARD¿ Irrigation, Syringe 70cc With Resectoscope Tip, Catheter Tip, Luer Adapter And Cap, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

Z-0735-2017
Recall number
Z-0735-2017
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard, Inc.
Quantity
452,728 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Package Defect
Sterility assurance reason.sterility_assurance · v1.0.0
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Code information

Product Code: 0038460, Lot Numbers: NGZC3768, NGZC5029, NGZD0924, NGZD1664, NGZD1983, NGZD3103, NGZD3241, NGZD3989, NGZD4053, GZD4923, NGZE1190, NGZE2134, NGZE3406, NGZF0305, NGZF1546, NGZF2589, NGZF3934, NGZF4488 and NGZF4885.

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.

device · product 2 of 4

BARD¿ 70cc Piston Syringe with Catheter Tip, Luer Adapter and Cap, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

Z-0736-2017
Recall number
Z-0736-2017
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard, Inc.
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Package Defect
Sterility assurance reason.sterility_assurance · v1.0.0
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Code information

Product Code: 0038470, Lot Numbers: NGZC3890, NGZC4955, NGZD0763, NGZD2107, NGZD3104, NGZD3990, NGZD4739, NGZE1149, NGZE2054, NGZE3535, NGZF0244, NGZF1565, NGZF2670, NGZF4104 and NGZF5006.

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.

device · product 3 of 4

BARD¿ Piston Syringe, 60cc, Rx Only, Sterile, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

Z-0737-2017
Recall number
Z-0737-2017
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard, Inc.
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Package Defect
Sterility assurance reason.sterility_assurance · v1.0.0
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Code information

Product Code: 750375, Lot Numbers: NGZC4960, NGZD3108, NGZE1244, NGZE3556 and NGZF2584.

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.

device · product 4 of 4

BARDIA¿ 60cc Piston Irrigation Syringe, Sterile, Rx Only, The BARD¿ Syringe is available in a single use plastic design which features a 60cc or 70cc capacity graduated barrel. It has a thumb ring plunger for one-handed use. A catheter adapter tip and Luer adapter tip are included. BARD¿ Syringe allows one-hand use with a 60cc or 70cc graduated barrel and thumb-ring plunger and is indicated for catheter irrigation use. BARD¿ Syringe is intended for Cytoscope or Resectoscope irrigation, catheter irrigation and Foley catheter balloon inflation.

Z-0738-2017
Recall number
Z-0738-2017
Initiated
August 03, 2016
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard, Inc.
Quantity
Unavailable

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Package Defect
Sterility assurance reason.sterility_assurance · v1.0.0
Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Package Defect: Products may be at risk for having a slit defect on the package and that may affect the product sterility.

Code information

Product Code: 802065, Lot Numbers: NGZC4950, NGZD2121, NGZD4043, NGZD4876, NGZE2323, NGZE3389, NGZF0189, NGZF2494 and NGZF4014.

Distribution pattern

Worldwide Distribution - US (nationwide) and Internationally to Australia, New Zealand, Canada, Mexico, France and Italy.