Reported Apr 20, 2022 · Terminated
CLARAVUE Pre-wired Electrode - IP SET M5 RT ADULT-US Model: 32028778 50601-US
Graphic Controls Acquisition Corporation
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: Graphic Controls Acquisition Corporation · 400 Exchange St · Buffalo, NY · 14204-2064
Is this the product you have?
- CLARAVUE Pre-wired
- Electrode - IP SET M5 RT ADULT-US Model32028778 50601-US
- Lot codes and dates
- All lots UDI03700506307333
- Amount recalled
- 19470 units
This recall covers 6 products
The agency filed one notice per product. You are reading one of them; the other 5 are below.
Where it was sold
Why it was recalled
Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown , an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the specification and delivers an inefficient electrical charge which may result in an ineffective defibrillation.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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