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Bio Protech
BIO PROTECH USA, INC. · Model T716-50 · UDI-DI 00817120020135
DRX
Prescription
1
510(k) clearances
1,611
Adverse events (24 deaths)
20
Recalls
192
Facilities
Description
T716-50: TElectrode, 43mm x 45mm Oval, PE Foam, General, Stress & Holter, 50pc/pouch, 20 pouches/box, 1,000 pcs per Master Case
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-03-15 | Graphic Controls Acquisition Corporation | 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 require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | 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 require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | 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 require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | 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 require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | 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 require |
| 2022-03-15 | Graphic Controls Acquisition Corporation | 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 require |
| 2021-10-06 | 3M Company - Health Care Business | Potential for breakage of the ECG electrode carbon stud from the eyelet. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
| 2020-09-15 | 3M Company - Health Care Business | Corrosion could cause performance failures in the product. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.