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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 72596

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

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Event summary

Timeline bucket
October 27, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Procedure Products, 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

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

U-SDN 2 Part Ultra Modified Seldinger Needles, NS/37-0387. All needles were sold in bulk, non-sterile, and intended for further processing. Needles are packaged in zipper-bags, 300 pieces per bag, with shipment occurring in a corrugated cardboard box. Needles consist of a stainless steel cannula with a molded plastic hub. This needle is intended to be placed over the guidewire to enlarge the opening in the vessel. Vessel dilator, for percutaneous catheterization.

Z-0355-2016
Recall number
Z-0355-2016
Initiated
October 27, 2015
Classification
Class II
Status
Terminated
Recalling firm
Procedure Products, Inc.
Quantity
1100 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Nonconforming Material/Component

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm had received a complaint alleging that a medical professional had difficulty inserting a guide wire into a needle

Code information

Lot 9184-A

Distribution pattern

Distributed in the states of MT and NY.