Medline medical convenience kits recall
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, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
Why was Medline medical convenience kits recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25IBN161; Medline SKU VASC1061, UDI/DI each 10889942464722, UDI/DI case 40889942464723, Lot Number 25GBF769; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, Lot Number 25HBN798; Medline SKU VASC1074, UDI/DI each 10889942611751, UDI/DI case 40889942611752, 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; Medline SKU VASCSHPOFF1, UDI/DI each 10889942405503, UDI/DI case 40889942405504, Lot Number 25GBL526; Medline SKU VASCSLPON1, UDI/DI each 10889942405510, UDI/DI case 40889942405511, Lot Number 25GBL070.
- 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, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
- Recalling firm
- Medline Industries, LP
- Quantity
- 1698 kits
- Distribution
- 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 date
- April 15, 2026
- Classification
- Class I
- Status
- Ongoing
- Agency
- FDA (device)