FDA recall Z-2689-2024

Stryker Sustainability Solutions · Class II · device

Product

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

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.

Distribution

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

Key facts

Status
Ongoing
Initiation date
2024-07-02
Report date
2024-08-28
Voluntary/Mandated
Voluntary: Firm initiated
Location
Tempe, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2689-2024