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

Medical DevicesSource: FDA (device) · Date: 2026-04-15

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

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. DELIVERY PACK, Medline SKU # DYNJ42892F; 2. DELIVERY PACK, Medline SKU # DYNJ42892G.
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 # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25GMD696; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25EMJ573; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25DMC646; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 25BMD630; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24LMA523; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24KMA084; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24JME306; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24FME624; Medline SKU # DYNJ42892F, UDI/DI each10195327693718, UDI/DI case 40195327693719, Lot Number : 24EMF099; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26BMH149; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 26AMD029; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25KMA060; Medline SKU # DYNJ42892G, UDI/DI each10198459504570, UDI/DI case 40198459504571, Lot Number : 25IMA514.
Product quantity
966 kits
Voluntary mandated
Voluntary: Firm initiated
City
Northfield
State
IL
Country
United States
Event id
98598
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