Reported Jun 5, 2013 · Terminated
adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1. Product…
TZ Medical Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: TZ Medical Inc. · 17750 SW Upper Boones Ferry Rd Ste 150 · Portland, OR · 97224-7086
Is this the product you have?
- adult defibrillation, cardioversion, pacing, monitoring Disposable Electrodes, Model P-211-M1 and P-214-M1
- Product UsageUsed by trained professionals in hospitals, doctors offices, and Emergency Medical Services for adult low-energy defibrillation, transcutaneous pacing, cardioversion and monitoring
- Lot codes and dates
14 of 14 products
Products covered by this recall Model / number Product as published P-211-M1Lot numbers: Y081712-17 — Y081712-18 — Y081712-19 — Y081712-20 — Y112612-08 — Y112612-09 — Y112612-10 — Y112612-11 — Y112612-12 — Y112612-13 P-214-M1and Y020113-07. Lot numbers: Y081712-04 — Y112612-24 — Y112612-23 — and Y031913-10. - Amount recalled
- US: 10,410 pieces; Outside US: 100 pieces
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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