Graphic Controls Acquisition Corporation recalls CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
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…
Read the official notice →- Date
- 2022-04-20
- Country
- United States
- Brand
- Graphic Controls Acquisition Corporation
- Product
- CLARAVUE Pre-wired Electrode - IP SET M3 RT ADULT-US Model: 32028777 50600 US
- Classification
- Class II
- Units
- US Nationwide distribution in the States of AR, CA, CO, FL, IN, KS, MA, MN,…
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
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- Check the product name, strength and lot number against the official notice.
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