Z-2268-2024 Class II Ongoing

Recalled by Stryker Sustainability Solutions — Phoenix, AZ

Recall Details

Product Type
Devices
Report Date
July 10, 2024
Initiation Date
May 10, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
6 units

Product 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 for Recall

Diagnostic electrophysiology (EP) catheters do not meet testing requirements.

Distribution Pattern

International distribution to the country of Japan.

Code Information

(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402