FDA-Device2024-07-10Class II

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

Stryker Sustainability Solutions
Hazard

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

Sold states
International distribution to the country of Japan.
Affected count
6 units
Manufactured in
10232 S 51st St, N/A, Phoenix, AZ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2268-2024

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