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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63136

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

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Event summary

Timeline bucket
September 07, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
C.R. Bard, Inc., Urological Division

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

8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.

Z-0010-2013
Recall number
Z-0010-2013
Initiated
September 07, 2012
Classification
Class II
Status
Terminated
Quantity
4,032 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap.

Code information

Catalog # 165808, Lot # NGWA1111

Distribution pattern

Nationwide distribution: USA and Puerto Rico