FDAFDA · Food and drugs·Recall number Z-2268-2024
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm, STERILE.EO, Rx Only
Published July 10, 2024 · Recall initiated: May 10, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Sustainability Solutions
- Distributor
- International distribution to the country of Japan.
- Lot
- (UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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