Medline Industries, LP: NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3. MTO,SYRINGE,10ML,T

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: 1752096 kits Lot/code info: Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000073035; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000075896; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000078648; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082387; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000082384; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000087087; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093180; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000093741; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000095735; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102248; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000102694; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000105537; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000107947; Medline SKU # 60010027, UDI/DI each 10193489040166, UDI/DI case 30193489040160, Lot Number: 0000113756; Medline SKU # 60010027, UDI/DI each 10193489

UPC codes

10193489040166, 30193489040160, 10193489087246, 20193489087243, 10193489040197, 10193489040210, 30193489040214, 10193489040234, 20193489040217, 10193489040319, 20193489040231, 10193489040333, 20193489040316, 10193489040340, 20193489040330, 10193489040388, 30193489040382, 10193489040449, 20193489040385, 10193489040456, 20193489040453, 10193489040470, 30193489040474, 10193489040579, 30193489040573, 10193489040593, 30193489040597, 10193489089219, 30193489089213, 10193489040685, 20193489089216, 10193489040715, 30193489040719, 10193489040739, 20193489040712, 10193489040746, 20193489040736, 10193489040753, 20193489040743, 10193489040869

Source

Official record: FDA (Device enforcement) ↗

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