medical Class II Updated 2018-11-21

Stryker Sustainability Solutions recalls Stryker Sustainability Solutions LASSO NAV eco Reprocessed D

Recalled Product

Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.

Hazard / Issue

Electrophysiology catheters were identified to be item # D134903 and distributed. It was subsequently determined that these catheters are item # D134909, which is not approved for reprocessing.

Issued by

FDA

Affected States: KS

Lot/Code Info: Item Number Serial Number D134903 2519054 D134903 2534027 Note: Item # D134909 is not approved for reprocessing by Stryker s Sustainability Solutions Division. Therefore, SSS does not create or possess D134909 labeling. SSS did not receive labeling from the manufacturer.

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