Stryker Sustainability Solutions: Device Recall

Recall #Z-2689-2024 · 07/02/2024

Class II: Risk

Recall Details

Recall Number
Z-2689-2024
Classification
Class II
Product Type
Device
Recalling Firm
Stryker Sustainability Solutions
Status
Ongoing
Date Initiated
07/02/2024
Location
Tempe, AZ, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
38,850

Reason for Recall

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 Description

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

Distribution Pattern

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

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.