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.
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G.
Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25GMD696; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25EMJ573; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25DMC646; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25BMD630; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24LMA523; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24KMA084; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24JME306; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24FME624; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24EMF099; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26BMH149; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26AMD029; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25KMA060; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25IMA514.
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.