Medline Industries, LP: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYN

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: 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). Quantity: 2154 units Lot/code info: Medline SKU # DYNJ57032D, UDI/DI each 10198459183850, UDI/DI case 40198459183851, Lot Number: 25HBN999; Medline SKU # DYNJ57032D, UDI/DI each 10198459183850, UDI/DI case 40198459183851, Lot Number: 25HBO039; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24JBC741; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24IBM270; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24IBE756; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24GBC735; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24FBF002; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24DBC238; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 24ABY360; Medline SKU # DYNJ64026C, UDI/DI each 10195327550059, UDI/DI case 40195327550050, Lot Number: 23LBH735; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 26ABP305; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 26ABI725; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25KBD893; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25HBM531; Medline SKU # VASC1650, UDI/DI each 10198459209666,

UPC codes

10198459183850, 40198459183851, 10195327550059, 40195327550050, 10198459209666, 40198459209667

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.