Z-1438-2013Class II

adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1

Name: Z-1438-2013 adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1
Creator: TZ Medical Inc.
Published: 2013-04-30
License: https://open.fda.gov/license/

TZ Medical Inc. / initiated 2013-04-30 / Terminated / root cause: manufacturing process

FDA source

TZ Medical Inc. began a recall of adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product Usage: Used by trained professionals in... on 2013-04-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1438-2013
Classification: Class II
Status: Terminated
Initiated: 2013-04-30
Posted: 2013-05-30
Terminated: 2013-09-05
Recalling firm: TZ Medical Inc.
Product: 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.
Product code: DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive)
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
Root cause tag: manufacturing process
FDA root cause: Process control
Action: TZ Medical Inc. started notifying their customers by telephone on April 30, 2013. The firm followed up with an Urgent: Medical Device Recall notification letter dated May 14, 2013, to their consignees. TZ Medical Inc., Representatives have will contact all affected customers and arrange for the replacement of the effected product in stock with inspected product. For any questions about this recall, please fax to 503-639-0239.
Quantity in commerce: US: 10,410 pieces; Outside US: 100 pieces
Distribution: Worldwide distribution - USA (nationwide) and Chile.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1438-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1438-2013	Class II	Terminated	Voluntary: Firm initiated	2013-06-05	2013-05-30

Product code DRO

K983196Class IIPadtak Pace/defib/cardiovert Monitoring Electrode(s)Tz Medical, Inc. / cleared 1999-09-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)