Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70457

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

Open FDA event record

Event summary

Timeline bucket
January 28, 2015
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

9F Plastic Dual Port; The port systems are totally implantable vascular access devices. They consist of an injection port, a self-sealing membrane and a detachable catheter. The port systems provide repeated vascular access and are applicable for delivery of: medications, intravenous fluids, blood products, parenteral nutrition, and for venous blood sampling.

Z-1527-2015
Recall number
Z-1527-2015
Initiated
January 28, 2015
Classification
Class II
Status
Terminated
Quantity
325

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The dual port with catheters was not covered under FDA clearance.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

PMA

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The dual port with catheters was not covered under FDA clearance.

Code information

Model No. MR592090A, MR592090P; with Lot Nos.: MAKT120 EXP. DATE 04/28/2012, MAXH410 EXP. DATE 06/28/2014, MAXF610 EXP. DATE 10/28/2014, MBFC140 EXP. DATE 05/28/2016, MBGH020 EXP. DATE 08/28/2016, MBHS100 EXP. DATE 11/28/2016, MAKT130 EXP. DATE 04/28/2012, MBAQ860 EXP. DATE 07/28/2015, MBHP980 EXP. DATE 11/28/2016, MBKJ110 EXP. DATE 03/28/2017

Distribution pattern

Worldwide distribution. US nationwide, Canada, Brazil, and United Arab Emirates.