FDA Enforcement
Class II
Terminated
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Recall: Z-0467-2019
·
Reported November 21, 2018
Enforcement
- Recall Number
- Z-0467-2019
- Event ID
- 81321
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Sustainability Solutions
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 21, 2018
- Initiation Date
- August 23, 2018
- Classification Date
- November 14, 2018
- Termination Date
- February 4, 2021
- Address
- 1810 W Drake Dr, Tempe, AZ, 85283-4327, United States
Description
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
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 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.
Distribution
US: KS OUS: None
Quantity
2