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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 82415

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

Open FDA event record

Event summary

Timeline bucket
March 13, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Medical Components, Inc dba MedComp

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

14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422

Z-1149-2019
Recall number
Z-1149-2019
Initiated
March 13, 2019
Classification
Class II
Status
Terminated
Quantity
6830

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Finished device change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Code information

MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MCFR460 MCFT410 MCFY850 MCFZ660 MKAD410 MKAN270 MKAP300 MKAT100 MKAX320 MKBA190 MKBK940 MKBL210 MKBP450 MKBV570 MMAA170 MMAD480 MMAS020

Distribution pattern

Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.