Exact FDA event identifier

Event 87333

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

Open FDA event record

Event summary

Timeline bucket: February 01, 2021
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Epimed International, 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

Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less

Z-1276-2021

Recall number: Z-1276-2021
Initiated: February 01, 2021
Classification: Class II
Status: Terminated
Recalling firm: Epimed International, Inc.
Quantity: 5835 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

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

Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off

Code information

Lot Numbers: 11247915, 11248510, 11248553, 11248938, 11248985, 11249049

Distribution pattern

US Nationwide distribution