Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29 in 2106381-002 ECG Leadwire set, 5-lead, snap, AHA, 130 cm/ 51 in 2106381-003 ECG Leadwire set, 5-lead, snap, IEC, 74 cm/ 29 in 2106381-004 ECG Leadwire set, 5-lead, snap, IEC, 130
Check against the official notice below — it lists the full affected range.
GE Healthcare, LLC is recalling ECG leadwire sets with snap ends used in cardiac care. The recalled products are 5-lead ECG leadwire sets in two lengths (74 cm and 130 cm) distributed worldwide, including throughout the United States, Puerto Rico, and numerous other countries. Approximately 58,045 units have been distributed globally, with 31,108 units in the United States.
The ECG trunk cables and leadwires in these sets may reduce the amount of energy reaching a patient during defibrillation, which could limit the success of defibrillating an abnormal heart rhythm. The source does not specify a remedy or action that affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
Reason for recall: ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm. Distribution: Worldwide Distribution: US (nationwide) including Puerto Rico, and countries of: Australia, Austria, Azerbaijan, Bangladesh, Belarus, Belgium, Bermuda, Bolivia, Bosnia and Herzegovina, Brazil, Bulgaria, Canada, Chile, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, El Salvador, Estonia, Finland, France, Germany, Greece, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Quantity: 58,045 units (31,108 US; 26937 OUS) in total Lot/code info: product does not have lot or serial codes REF/Catalog Number GTIN/UDI 2106381-001 00840682139953 2106381-002 00840682140201 2106381-003 none 2106381-004 none 2106381-005 00840682139854 2106383-001 00840682140126 2106383-002 00840682140096 2106383-003 none 2106383-004 none 2106383-005 00840682140034 2106385-001 00840682139588 2106385-002 00840682140119 2106385-003 none 2106385-004 none 2106394-003 00840682140102 2106395-001 00840682139649 2106396-001 none 2106396-002 none
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.