FDA Medical Device · 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

Class II · Ongoing

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

Affected lots / codes — check yours against this(UDI):00885825011680/Serial #: 4175411, 4202651, 4116975, 4202652, 4175410, 4175402

Recalling firm: Stryker Sustainability Solutions, Phoenix, AZ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 6 units
Distribution: International distribution to the country of Japan.
Recall initiated: May 10, 2024
Classified: July 3, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-2268-2024%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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