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Recall Observatory FDA recall evidence

Device product

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

Z-0467-2019

August 23, 2018

Class II

Product summary

Firm
Stryker Sustainability Solutions
Event
Event 81321
Status
Terminated
Classification
Class II
Quantity
2
Official record key
device-enforcement:Z-0467-2019

Official wording

Reason: 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.

Code information: 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.

Distribution pattern: US: KS OUS: None

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.