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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 70896

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

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Event summary

Timeline bucket
March 30, 2015
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Baylis Medical Corp *

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

ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.

Z-1442-2015
Recall number
Z-1442-2015
Initiated
March 30, 2015
Classification
Class II
Status
Terminated
Recalling firm
Baylis Medical Corp *
Quantity
58 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

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

Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.

Code information

Lots CIFA180814 and CIFA080914

Distribution pattern

US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR