[pending] Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring
Pending LLM rewrite. Source: FDA_DEVICE Z-1721-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medlin
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Medline SKU # CDS780138K
- UDI/DI each 10198459205552
- UDI/DI case 40198459205553
- Lot Number: 25EBR802
- Medline SKU # DYNJ36478B
- UDI/DI each 10889942814619
- UDI/DI case 40889942814610
- Lot Number: 25AMH487
- Lot Number: 24JMC622
- Lot Number: 24EMD869
- Medline SKU # DYNJ910458
- UDI/DI each 10195327692469
- UDI/DI case 40195327692460
- Lot Number: 24LLA039
- Medline SKU # VASC1081C
- UDI/DI each 10195327054519
- UDI/DI case 40195327054510
- Lot Number: 25HBU295
- Medline SKU # VASC1510
- UDI/DI each 10195327686888
Distribution
Distributed nationwide across the United States.
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