Medline Industries, LP: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follo

Company / brand

Medline Industries, LP

Product

Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO PACK, Medline SKU # DYNJ57032D; 2. NEURO INTERVENTIONAL RADIOLOGY, Medline SKU # DYNJ64026C; 3. NEURO INERVENTIONAL RADIOLOGY, Medline SKU # VASC1650.

Reason / 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.

Classification

Class I

Status

Ongoing

Distribution / sold at

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).

Recall initiated

2026-02-27

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.

Product quantity

2154 units

Voluntary mandated

Voluntary: Firm initiated

City

Northfield

State

IL

Country

United States

Event id

98598

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