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Stryker Sustainability Solutions recalls Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Recalled August 28, 2024 · FDA recall Z-2689-2024 · Stryker Sustainability Solutions
Hazard
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended. · FDA Class II
Units
38,850
Sold at
US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
Description
Disposable 5 lead cable and lead wire system package that should contain lead systems, lead telemetry systems and a dual connect cable, may in fact contain, different ECG Leads, which are not approved for reprocessing, but that may have been reprocessed, which may lead to devices not performing as intended.
Product
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Manufacturer(s)
Stryker Sustainability Solutions
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →