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Curaplex

BOUND TREE MEDICAL, LLC · Model 2751-50487 · UDI-DI 00817617026640

DRX Prescription
10
510(k) clearances
1,611
Adverse events (24 deaths)
20
Recalls
192
Facilities

Description

Curaplex 50mm X 48mm foam electrode, wet gel, 60 ea/pouch

Recalls

DateFirmReason
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2022-03-15Graphic Controls Acquisition CorporationInstructions 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
2021-10-063M Company - Health Care BusinessPotential for breakage of the ECG electrode carbon stud from the eyelet.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.
2020-09-153M Company - Health Care BusinessCorrosion could cause performance failures in the product.

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Data 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.