Z-0467-2019 Class II Terminated
FDA device recall Z-0467-2019 was initiated by Stryker Sustainability Solutions on Aug 23, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated Feb 4, 2021). Affected quantity: 2.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 21, 2018
- Initiation Date
- Aug 23, 2018
- Termination Date
- Feb 4, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Stryker Sustainability Solutions LASSO NAV eco Reprocessed Diagnostic EP Catheters designed to obtain electrophysiological mapping of the cardiac structures of the heart.
Reason for Recall
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.
Distribution Pattern
US: KS OUS: None
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0467-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026