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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80887

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

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Event summary

Timeline bucket
August 22, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smiths Medical ASD 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

Jelco(R) ViaValve(TM) safety intravenous (I.V.) catheters, 18G x 1 1/4", Model Number REF 3265, MOD 10 The Jelco(R) ViaValve(TM) safety I.V. catheter is a sterile, non pyrogenic, single use, radiopaque intravascular catheter device used for the administration of medically prescribed fluids, designed to reduce the risk of accidental secondary needle sticks.

Z-1218-2019
Recall number
Z-1218-2019
Initiated
August 22, 2018
Classification
Class II
Status
Terminated
Recalling firm
Smiths Medical ASD Inc.
Quantity
136,600 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

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Inspect official wording and provenance

Reason for recall

Several lots of Jelco¿ ViaValve" safety intravenous (I.V.) catheters exhibited a V shaped puncture at the base of the catheter near the hub due to an adjustment that was made in the manufacturing process.

Code information

Lot Numbers: 3584467, 3584468, 3584469, 3576073, 3576233, 3578511, 3578512

Distribution pattern

Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, and New Zealand.