Recall Z-2689-2024— Stryker Sustainability Solutions
Class II · Ongoing
Class II FDA medical device recall by Stryker Sustainability Solutions, initiated 2024-07-02. FDA's recall record names no specific 510(k) clearance for this event. Product: Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A. Reason: 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..
- Recalling firm
- Stryker Sustainability Solutions
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-07-02
- Firm location
- Tempe, AZ, United States
Product description
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.