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.
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: 2980 kits Lot/code info: Medline SKU # DYNJ68037C, UDI/DI each 10198459239328, UDI/DI case 40198459239329, Lot Number: 25HBV397; Medline SKU # DYNJ89845, UDI/DI each 10198459292460, UDI/DI case 40198459292461, Lot Number: 25CBU222; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26BBC195; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 26ABI611; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25LBK402; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25KBH371; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25IBK975; Medline SKU # DYNJ89845A, UDI/DI each 10198459490965, UDI/DI case 40198459490966, Lot Number: 25HBQ426.
10198459239328, 40198459239329, 10198459292460, 40198459292461, 10198459490965, 40198459490966
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.