Medline manifold kits recalled for potential syringe disconnection
Medline Industries is recalling five medical convenience kits that contain syringes with rotating adapters that may unwind during use. This could cause the syringe to loosen or fully disconnect from the manifold. No injuries have been reported.
From the FDA notice · Read the official notice ↗ · All Medline recalls
What to do
- Check if you have one of the five affected Medline SKU kits (VASC1061, VASC1074, VASC1198, VASCSHPOFF1, or VASCSLPON1)
- Verify the lot number matches those listed in the recall notice
- Stop using the kit immediately if you have an affected lot
- Contact your Medline representative or the FDA for instructions on returning or replacing the kit
Is yours affected?
Compare your label or packaging with 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, Medline SKU VASC1198; 4. MANIFOLD KIT - 500PSI OFF, Medline SKU VASCSHPOFF1; 5. MANIFOLD KIT LOW PRESSURE ON, Medline SKU VASCSLPON1.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 19 products — see all of them.
Details
- Units affected
- 1698 kits
- Illnesses reported
- None reported
- Manufactured in
- 3 Lakes Dr, Northfield, IL, United States
- Classification
- Class I
- Recall number
- Z-1715-2026
In the FDA's words
- Description
- 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. 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. 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. 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). Affected quantity: 1698 kits
- Hazard
- 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.
19 products in this recall
Medline NAMIC angiographic syringes recalled for disconnection risk
Medline is recalling 19 NAMIC angiographic syringes and Medline convenience kits that contain them. The syringe's rotating adaptor can unwind during use, which may loosen or fully disconnect the syringe from the manifold. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 7008500…Z-1712-2026 · 2630369 units
- 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,…Z-1713-2026 · 192690 units
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: CVOR ANGIOGR…Z-1714-2026 · 3120 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CSTM MA… (this page)Z-1715-2026 · 1698 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. CATH LA…Z-1716-2026 · 17902 kits
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3.…Z-1717-2026 · 149439 kits
- NAMIC Angiographic Syringe, labeled as follows: 1. SYRINGE,20ML,CONTROL,-,PKG, Medline SKU 70075027; 2. SYRINGE,10ML,TR/FR,RA,W/RES, Medline SKU 70085007; 3.…Z-1718-2026 · 1752096 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. NON VAS…Z-1719-2026 · 2980 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: SPECIAL PR…Z-1720-2026 · 762 units
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. HEAD AN…Z-1721-2026 · 594 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROS…Z-1722-2026 · 20 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: MINOR PLAS…Z-1723-2026 · 60 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. MTS RH…Z-1724-2026 · 79843 units
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: GLOVE PACK…Z-1725-2026 · 240 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ANGIO P…Z-1726-2026 · 2154 units
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. DELIVER…Z-1727-2026 · 966 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. ROBOTIC…Z-1728-2026 · 439 kits
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: TAVR PACK,…Z-1729-2026 · 108 units
- Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDE…Z-1730-2026 · 82 kits
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