FDAClass IIJuly 10, 2024

Stryker Sustainability Solutions recall

Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm…

Why was Stryker Sustainability Solutions recalled?

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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Stryker Sustainability Solutions, BW Lasso 2515 NAV eco Variable Diagnostic EP Catheter, REF: D134301, ELECTRODES: 22, spacing:2-6-2MM, Length 115 cm…
Recalling firm
Stryker Sustainability Solutions
Quantity
6 units
Distribution
International distribution to the country of Japan.
Recall date
July 10, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
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