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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 89288

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

Open FDA event record

Event summary

Timeline bucket
January 27, 2022
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

2 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 2

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS14C

Z-0666-2022
Recall number
Z-0666-2022
Initiated
January 27, 2022
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard Inc
Quantity
2120 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential to leak from the catheter where it connects to the drain bag

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

There is a potential to leak from the catheter where it connects to the drain bag

Code information

Serial Number/UDI NGEWX106/(01)00801741183232(17) NGEWX143/(01)00801741183232(17) NGFQ0368/(01)00801741183232(17) NGEW9106/(01)00801741183232(17)

Distribution pattern

US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.

device · product 2 of 2

BARD SURESTEP INTERMITTENT CATHETER TRAY, 14Fr, REF INTS16C

Z-0667-2022
Recall number
Z-0667-2022
Initiated
January 27, 2022
Classification
Class II
Status
Terminated
Recalling firm
C.R. Bard Inc
Quantity
1620 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a potential to leak from the catheter where it connects to the drain bag

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

There is a potential to leak from the catheter where it connects to the drain bag

Code information

Serial Number/UDI NGEWX117 (01)00801741183249(17) NGEXX133/(01)00801741183249(17) NGEY0842/(01)00801741183249(17) NGEZ1823/(01)00801741183249(17)

Distribution pattern

US Nationwide distribution in the states of GA, ME, NJ, WI, MN, SD, CO, ND, ID, IL, FL, LA, MD, PA, OH, NE.