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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 68456

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

Open FDA event record

Event summary

Timeline bucket
January 11, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SteriGear, LLC

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

SteriGear Urinary Drain Bag with Fig Leaf Cover, 2000 ml, REF 10270, The Fig Leaf, SteriGear 362 S. University Avenue, provo, UT 84601, 1-800-398-3259, SteriGear.com, Sterile, EO Urinary Drainage Collection Kit, for Indwelling Catheter. This device is intended to collect the Urine drained from an indwelling catheter

Z-1848-2014
Recall number
Z-1848-2014
Initiated
January 11, 2011
Classification
Class II
Status
Terminated
Recalling firm
SteriGear, LLC
Quantity
110,560

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

SteriGear notifed customers of circumstances in which The Fig Leaf urinary drain bag valve can close creating a negative pressure that can suck the non-return valve closed.

Code information

UPD 851616002007, Part 10270

Distribution pattern

Nationwide Distribution