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.
Issued by
FDA
Distribution: Nationwide (United States)
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, UDI/DI case 40198459209667, Lot Number: 25HBA055; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25EBC929; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25DBL096; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25DBD577; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25DBI493; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25ABI074; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 24LBG466; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 26BBG430; Medline SKU # VASC1650, UDI/DI each 10198459209666, UDI/DI case 40198459209667, Lot Number: 25LBC439.
✅ What Should You Do?
1Contact your healthcare provider immediately to discuss this recall.
2Stop using the device if it is safe to do so, and contact your provider.
3Follow the manufacturer's remedy instructions provided in the recall notice.
4Report device problems to FDA MedWatch or call 1-800-FDA-1088.