[pending] NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medl
Pending LLM rewrite. Source: FDA_DEVICE Z-1713-2026.
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
- NAMIC Angiographic Control Syringe, labeled as follows: 1. SYRINGE,7ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70083007; 2. SYRINGE,8ML,TR/FR,RA,W/RES,-,P/G, Medline SKU 70084007; 3. MTS,SYRINGE,8ML,TR/FR,RA,NO,RES,-,P/G, Medline SKU 70084017; 4. SYRINGE,7,ML,TR/FR,RA,W/RES,OE
- 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)
- 1. Medline SKU 70083007
- UDI/DI each 10193489065855
- UDI/DI case 30193489065859
- Lot Numbers: 0000077029
- 0000081537
- 0000084335
- 0000087347
- 0000089563
- 0000113792
- 0000115753
- 0000122956
- 0000127785
- 0000131986
- 0000158748
- 0000175535
- 0000187926
- 2. Medline SKU 70084007
- UDI/DI each 10193489065893
- UDI/DI case 30193489065897
- Lot numbers: 0000078186
Distribution
Distributed nationwide across the United States.
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