Stryker Sustainability Solutions recalls Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A

Recall date

July 2, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2689-2024

FDA classification

Class II

Brand / firm

Stryker Sustainability Solutions

Sold / distributed

US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A