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SynCardia Systems LLC Recall 92930

Description: SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO

SynCardia Systems LLC Recall 92930 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-0126-2024
Event ID92930
Event DescriptionSynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Product TypeDevices
DistributionUS: 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
Quantity114 units
Recall ReasonArtificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Device Classification20231101
Device Code InfoAll Lots/ UDI: 00858000003053
Center Classification Date20231020
Recall Initiation Date20230801
Recalling FirmSynCardia Systems LLC
Initial Notification Letter
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