Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A
Reported: August 28, 2024 Initiated: July 2, 2024 #Z-2689-2024
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.
Details
- Recalling Firm
- Stryker Sustainability Solutions
- Units Affected
- 38,850
- Distribution
- US Nationwide distribution in the states of FL, WY, AZ, CA, LA, TX, MI, OR, CO, MS, TN, WI.
- Location
- Tempe, AZ
Frequently Asked Questions
What product was recalled? ▼
Disposable 5 Lead Cable and Lead Wire System, 50 inches, REF: LW-309DS50/5A. Recalled by Stryker Sustainability Solutions. Units affected: 38,850.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 28, 2024. Severity: Moderate. Recall number: Z-2689-2024.
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