[pending] Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syring
Pending LLM rewrite. Source: FDA_DEVICE Z-1715-2026.
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. CSTM MANIFOLD KIT - TITUS, Medline SKU VASC1061; 2. CSTM MANIFOLD KIT - FRYE, Medline SKU VASC1074; 3. CRYO EP MANIFOLD KIT, M
- 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 VASC1061
- UDI/DI each 10889942464722
- UDI/DI case 40889942464723
- Lot Number 25IBN161
- Lot Number 25GBF769
- Medline SKU VASC1074
- UDI/DI each 10889942611751
- UDI/DI case 40889942611752
- Lot Number 25HBN798
- Lot Number 25GBL527
- Medline SKU VASC1198
- UDI/DI each 10193489664263
- UDI/DI case 40193489664264
- Lot Number 25GDA142
- Medline SKU VASCSHPOFF1
- UDI/DI each 10889942405503
- UDI/DI case 40889942405504
- Lot Number 25IBP989
- Lot Number 25GBL526
- Medline SKU VASCSLPON1
Distribution
Distributed nationwide across the United States.
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