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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 88317

2 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
December 28, 2017
Product types
Device
Classifications
Class II
Statuses
Completed
Recalling firm wording
Epimed International

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

2 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 2

NEO-KATH Epidural Catheter Set, REF 200-2430, Sterile

Z-2312-2021
Recall number
Z-2312-2021
Initiated
December 28, 2017
Classification
Class II
Status
Completed
Recalling firm
Epimed International
Quantity
132 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for stylet to protrude from the distal end of the catheter

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

Potential for stylet to protrude from the distal end of the catheter

Code information

Reference Number 200-2430, Lot Numbers 16308275 (Expiration August 2022), 16308382 (Expiration October 2022)

Distribution pattern

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.

device · product 2 of 2

NEO-KATH(TM) Caudal Set, REF 201-2430, Sterile

Z-2313-2021
Recall number
Z-2313-2021
Initiated
December 28, 2017
Classification
Class II
Status
Completed
Recalling firm
Epimed International
Quantity
140 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for stylet to protrude from the distal end of the catheter

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

Potential for stylet to protrude from the distal end of the catheter

Code information

Reference Number 201-2430, Lot Numbers 16308139 (Expiration August 2022), 16308383 (Expiration October 2022)

Distribution pattern

Worldwide distribution, with US distribution to CA, DE, OH, OK, PA, VA, WA, WV. International distribution to Canada and Iran.