ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG… — Class III medical device recall Z-1876-2019
Terminated recall by GE Healthcare, LLC, reported 2019-07-03, distributed nationwide. ECG trunk cables and leadwires may reduce the amount of energy reaching the patient during defibrillation, pot
| Recall number | Z-1876-2019 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | GE Healthcare, LLC, Waukesha, WI, United States |
| Recall initiated | 2019-05-10 |
| Classified | 2019-06-25 |
| Reported by FDA | 2019-07-03 |
| Terminated | 2024-05-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BD, BE, BG, BM, BO, BR, CA, CH, CL, CO, CR, CY, CZ, DE, DK, EC, EE, EG, ES, FI, FR, GB, GR, HK, HN, HU, ID, IE, IL, IN, IQ, IS, IT, JM, JO, JP, KE, KR, KW, LB, LK, LT, LV, MA, MT, MX, NG, NL, NO, NP, NZ, OM, PA, PL, QA, RO, RS, RU, SE, SG, SI, SK, SV, TH, TR, TT, TW, UA, UY, VN, ZA |
| UPC / GTIN / UDI-DI | 00840682139687, 00840682139779, 00840682139786, 00840682139830, 00840682139885, 00840682139960, 00840682140041, 00840682140232, 00840682140287, 00840682140348, 00840682140461, 00840682140522, 00840682140799 |
| Model numbers | 00840682139779, 00840682139960, 2106389-001, 2106389-002, 2106389-003 |
Product
ECG leadwire sets: REF/Catalog Number Description 2106389-001 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106389-002 ECG Leadwire set, 5-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106389-003 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106389-004 ECG Leadwire set, 5-lead, grouped, grabber, IEC, 130 cm/ 51 in 2106389-005 ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106389-006 ECG Leadwire set, 5-lead, grouped, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106390-001 ECG Leadwire set, 3-lead, grabber, AHA, 74 cm/ 29 in 2106390-002 ECG Leadwire set, 3-lead, grabber, AHA, 130 cm/ 51 in 2106390-003 ECG Leadwire set, 3-lead, grabber, IEC, 74 cm/ 29 in 2106390-004 ECG Leadwire set, 3-lead, grabber, IEC, 130 cm/ 51 in 2106391-001 ECG Leadwire set, 5-lead, grabber, AHA, 74 cm/ 29 in 2106391-002 ECG Leadwire set, 5-lead, grabber, AHA, 130 cm/ 51 in 2106391-003 ECG Leadwire set, 5-lead, grabber, IEC, 74 cm/ 29 in 2106391-004 ECG Leadwire set, 5-lead, grabber, IEC, 130 cm/ 51 in 2106391-005 ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106391-006 ECG Leadwire set, 5-lead, grabber, IEC, mix 74 cm/ 29 in, 130 cm/ 51 in 2106393-001 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 130 cm/ 51 in 2106393-002 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 130 cm/ 51 in 2106393-003 ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 in 2106393-004 ECG Leadwire set, 5-lead C2-6, grabber, IEC, 74 cm/ 29 in 2106397-001 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 74 cm/ 29 in 2106397-002 ECG Leadwire set, 6-lead, grouped, grabber, AHA, 130 cm/ 51 in 2106397-003 ECG Leadwire set, 6-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 in 2106398-001 ECG Leadwire set, 6-lead, grouped, grabber, IEC, 74 cm/ 29 in 2106398-002 ECG Leadwire set, 6-lead, grouped, grabber, 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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1876-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.