Reported Jul 3, 2019 · Terminated
Leadwire sets with snap ends: REF/Catalog Number Description 2106381-001 ECG Leadwire set, 5-lead, snap, AHA, 74 cm/ 29…
GE Healthcare, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.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: GE Healthcare, LLC · 3000 N Grandview Blvd · Waukesha, WI · 53188-1615
Is this the product you have?
- Leadwire sets with snap endsREF/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 cm/ 51 in 2106381-005 ECG Leadwire set, 5-lead, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-001 ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 in 2106383-002 ECG Leadwire set, 5-lead, grouped, snap, AHA, 130 cm/ 51 in 2106383-003 ECG Leadwire set, 5-lead, grouped, snap, IEC, 74 cm/ 29 in 2106383-004 ECG Leadwire set, 5-lead, grouped, snap, IEC, 130 cm/ 51 in 2106383-005 ECG Leadwire set, 5-lead, grouped, snap, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106383-006 ECG Leadwire set, 5-lead, grouped, snap, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106385-001 ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 in 2106385-002 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, AHA, 130 CM/ 51 IN 2106385-003 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 74 CM/ 29 IN 2106385-004 ECG LEADWIRE SET, 3-LD GROUPED, SNAP, IEC, 130 CM/ 51 IN 2106394-003 ECG Leadwire set, 5-lead V2-6, snap, AHA, 74 cm/ 29 in 2106395-001 ECG Leadwire set, 6-lead, grouped, snap, AHA, 74 cm/ 29 in 2106396-001 ECG Leadwire set, 6-lead, grouped, snap, IEC, 74 cm/ 29 in 2106396-002 ECG Leadwire set, 6-lead, grouped, snap, IEC, 130 cm/ 51 in The reusable ECG leadwire sets enable ECG monitoring with GE equipment requiring rectangular 11-pin ECG trunk cable. Use leadwire sets with ECG trunk cable or telemetry transmitter
- Lot codes and dates
- 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
- Amount recalled
- 58,045 units (31,108 US; 26937 OUS) in total
This recall covers 7 products
The agency filed one notice per product. You are reading one of them; the other 6 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, potentially limiting success of defibrillating the patients rhythm.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
Want the full recall guide?
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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