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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62238

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

Open FDA event record

Event summary

Timeline bucket
April 02, 2012
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

MRCTT80041 MedComp 8F Plastic Pro-Fuse(R) CT Low Profile Port with Attachable Chronoflex(R) Polyurethane Catheter. Power Injectable Implantable Infusion Port insertion kit.

Z-1868-2012
Recall number
Z-1868-2012
Initiated
April 02, 2012
Classification
Class II
Status
Terminated
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Packaging process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

Code information

Catalog number MRCTT80041, Lot # MDNK860, Exp 02/2015

Distribution pattern

Worldwide Distribution-USA (nationwide) including the states of GA and WA and the countries of Ireland and Turkey.