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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69412

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

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Event summary

Timeline bucket
September 29, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Coloplast Manufacturing US, 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

Coloplast Conveen Urine Collection Leg Bag, Product Numbers 5170, 5171, and 5174. Urine Collection Bag.

Z-0155-2015
Recall number
Z-0155-2015
Initiated
September 29, 2014
Classification
Class II
Status
Terminated
Quantity
217,540

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

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

Coloplast is recalling the Conveen Contour Leg Bag due to potential leakage from the bag seam when filled.

Code information

Lot Numbers: 3880261, 3880268, 3932929, 3932933, 3940329, 3940332, 3949825, 3949828, 3968997, 3969002, 3997492, 3997778, 3997782, 4006822, 4019572, 4019574, 4047072, 4047075, 4056422, 4056423, 4056428, 4073930, 4073934, 4092990, 4092991, 4100228.

Distribution pattern

Nationwide Distribution including Puerto Rico and the states of AL, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, LA, MD, MA, MI, MN, MS,MO,NE,NH, NJ, NY, NC, ND, OH, OK, OR, PA, RI, SC, TN, TX, UT, VA, WA, and WV.