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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 69182

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

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Event summary

Timeline bucket
September 04, 2014
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Teleflex Medical

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

Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.

Z-2661-2014
Recall number
Z-2661-2014
Initiated
September 04, 2014
Classification
Class II
Status
Terminated
Recalling firm
Teleflex Medical
Quantity
193,363 ea. + 1,140 units (total 194,503 units)

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
Misbranding

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling Change Control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.

Code information

Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: Product Code: 40214-000080, Lot numbers 14101 & 13301; Product Code: 402140-000140, Lot number: 14281; Product Code: 402140-0001160, Lot number: 13491; Product Code: 402140-000180, Lot number: 13391 and Product Code; 402140-000240, Lot numbers: 13391 & 14027.

Distribution pattern

Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzerland, Turkey, Portugal and Zambia.