[pending] Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring
Pending LLM rewrite. Source: FDA_DEVICE Z-1716-2026.
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. CATH LAB PACK-LF, Medline SKU 00-HCT055P; 2. INTERVENTIONAL CATH LAB PK-LF, Medline SKU DYNJ0376230Q; 3. ANGIOGRAPHY CATH LAB,
- 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 00-HCT055P
- UDI/DI each 10193489297393
- UDI/DI case 40193489297394
- Lot Number 24BBI341
- Lot Number 23LBP066
- Lot Number 23KBS305
- Lot Number 23JBA062
- Lot Number 23HBR594
- Lot Number 23DBR051
- Medline SKU DYNJ0376230Q
- UDI/DI each 10193489759303
- UDI/DI case 40193489759304
- Lot Number 24ABO014
- Lot Number 23KBW878
- Lot Number 23HBP761
- Lot Number 23FBW006
- Lot Number 23DBF403
- Medline SKU DYNJ23532C
- UDI/DI each 10193489460872
- UDI/DI case 40193489460873
Distribution
Distributed nationwide across the United States.
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