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: 149469 kits Lot/code info: Medline SKU 60010027, Lot Number 25EBF689; Medline SKU 60010027, Lot Number 25CBL960; Medline SKU 60010027, Lot Number 24LBO743; Medline SKU 60010195, Lot Number 25ABI082; Medline SKU 60010195, Lot Number 24IBJ827; Medline SKU 60010195, Lot Number 24HBO437; Medline SKU 60010195, Lot Number 24DBR149; Medline SKU 60010195, Lot Number 24CBF820; Medline SKU 60011433, Lot Number 26BBJ156; Medline SKU 60011433, Lot Number 26ABH642; Medline SKU 60011433, Lot Number 25KBJ356; Medline SKU 60011433, Lot Number 25HBQ865; Medline SKU 60011433, Lot Number 25FBS131; Medline SKU 60011433, Lot Number 25DBR246; Medline SKU 60011433, Lot Number 25CBS392; Medline SKU 60011433, Lot Number 25CBB739; Medline SKU 60011433, Lot Number 24JBR628; Medline SKU 60011433, Lot Number 24EBL302; Medline SKU 60011433, Lot Number 24BBS083; Medline SKU 60011433, Lot Number 23LBH316; Medline SKU 60011433, Lot Number 23JBP386; Medline SKU 60011433, Lot Number 23HBB765; Medline SKU 60011433, Lot Number 23FBC617; Medline SKU 60011433, Lot Number 23EBD152; Medline SKU 60011433, Lot Number 23DBR429; Medline SKU 60020323, Lot Number 25LBK008; Medline SKU 60020323, Lot Number 25JBJ120; Medline SKU 60020323, Lot Number 25HBQ807; Medline SKU 60020323, Lot Number 25GBA069; Medline SKU 60020323, Lot Number 25EBC643; Medline SKU 60020323, Lot Number 25CBE212; Medline SKU 60023904, Lot Number 26BBB137; Medline SKU 60023904, Lot Number 26ABL323; Medline SKU 60023904, Lot Number 25JBM214; Medline SKU 60023904, Lot Number 25EBM

Source

Official record: FDA (Device enforcement) ↗

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