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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72365

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

Open FDA event record

Event summary

Timeline bucket
August 13, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Nipro Medical Corporation

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

Nipro Safe Touch TULIP Safety Fistula Needle, FT+152530TP, for use as a blood access device for blood purification and for other treatments requiring an extracorporeal circuit of larger volumes of blood.

Z-0161-2016
Recall number
Z-0161-2016
Initiated
August 13, 2015
Classification
Class II
Status
Terminated
Recalling firm
Nipro Medical Corporation
Quantity
50,000 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Some 1 1/4" needles were packaged and labeled in the 1" blister package.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Some 1 1/4" needles were packaged and labeled in the 1" blister package.

Code information

Lot # 15C03

Distribution pattern

Indiana