FDA Enforcement
Class II
Ongoing
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
Recall: Z-2268-2024
·
Reported July 10, 2024
Enforcement
- Recall Number
- Z-2268-2024
- Event ID
- 94726
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- July 10, 2024
- Initiation Date
- May 10, 2024
- Classification Date
- July 3, 2024
- Address
- 10232 S 51st St, N/A, Phoenix, AZ, 85044-5205, United States
Description
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
Reason
Diagnostic electrophysiology (EP) catheters do not meet testing requirements.
Code Info
(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402
Distribution
International distribution to the country of Japan.
Quantity
6 units