SynCardia Systems LLC Recall 92930
Description: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
SynCardia Systems LLC Recall 92930 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | Z-0126-2024 |
Event ID | 92930 |
Event Description | SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO |
Product Type | Devices |
Distribution | US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia |
Quantity | 114 units |
Recall Reason | Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. |
Device Classification | 20231101 |
Device Code Info | All Lots/ UDI: 00858000003053 |
Center Classification Date | 20231020 |
Recall Initiation Date | 20230801 |
Recalling Firm | SynCardia Systems LLC |
Initial Notification | Letter |
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