Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510.

Reason: Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold.

Code information: Medline SKU # CDS780138K, UDI/DI each 10198459205552, UDI/DI case 40198459205553, Lot Number: 25EBR802; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 25AMH487; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 24JMC622; Medline SKU # DYNJ36478B, UDI/DI each 10889942814619, UDI/DI case 40889942814610, Lot Number: 24EMD869; Medline SKU # DYNJ910458, UDI/DI each 10195327692469, UDI/DI case 40195327692460, Lot Number: 24LLA039; Medline SKU # VASC1081C, UDI/DI each 10195327054519, UDI/DI case 40195327054510, Lot Number: 25HBU295; Medline SKU # VASC1510, UDI/DI each 10195327686888, UDI/DI case 40195327686889, Lot Number: 24GBO586; Medline SKU # VASC1510, UDI/DI each 10195327686888, UDI/DI case 40195327686889, Lot Number: 24EBG342.

Distribution pattern: Worldwide distribution: US (nationwide) including Puerto Rico (PR) and OUS (foreign) to countries of: Canada (CA), Netherlands (NL), Australia (AU), Korea, Republic of (KR), Sri Lanka (LK), Pakistan (PK), Japan (JP), United Arab Emirates (AE), Singapore (SG) and Slovakia (SK).