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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65120

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

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Event summary

Timeline bucket
April 30, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
TZ Medical 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

adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring.

Z-1438-2013
Recall number
Z-1438-2013
Initiated
April 30, 2013
Classification
Class II
Status
Terminated
Recalling firm
TZ Medical Inc.
Quantity
US: 10,410 pieces; Outside US: 100 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discolor

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

TZ Medical Inc is recalling its P-211-M1 and P-214-M1 Medtronic / Physio Control Compatible transparent defibrillation electrodes because it may contain a defective white wire on the connector assembly. If a failure were to occur, the end user would be able to identify the failure by inspecting the white wire 1/4 inch from the Gray Medtronic / Physio adapter. The consignees will notice discolor

Code information

Model P-211-M1 Lot numbers: Y081712-17; Y081712-18; Y081712-19; Y081712-20; Y112612-08; Y112612-09; Y112612-10; Y112612-11; Y112612-12; Y112612-13; and Y020113-07. Model P-214-M1 Lot numbers: Y081712-04; Y112612-24; Y112612-23; and Y031913-10.

Distribution pattern

Worldwide distribution - USA (nationwide) and Chile.