CLASS II Device recall · Reported 5 Jun 2013 · FDA Enforcement Report
adult defibrillation, cardioversion, pacing recalled by TZ Medical
TZ Medical is recalling adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, distributed nationwide in the US. The recall was initiated on 30 Apr 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1438-2013
- FDA event ID
- 65120
- Recalling firm
- TZ Medical, Portland, OR
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2013
- FDA classified
- 30 May 2013
- Reported
- 5 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Device Malfunction
- Device type
- Patient Monitors
Timeline
| 30 Apr 2013 | Recall initiated by company | |
| 30 May 2013 | Classified by FDA | +30 days |
| 5 Jun 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution - USA (nationwide) and Chile.
Questions about this recall
Is adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes recalled?
Yes. TZ Medical recalled adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes on 30 Apr 2013. The recall is Class II and its status is Terminated. Recall number Z-1438-2013.
Why was it recalled?
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
Which lots are affected?
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.
Where was it sold?
Worldwide distribution - USA (nationwide) and Chile.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |