FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline catheter lab kits recalled for syringe adapter disconnection risk

OTHERNationwide distribution

Stop using recalled Medline catheter lab kits

Medline medical convenience kits containing NAMIC angiographic syringes may have a rotating adapter that can unwind during use. This could cause the syringe to loosen or fully disconnect from the manifold during cardiac catheterization procedures. No injuries have been reported, but the disconnection poses a risk during medical use.

  • Check if your facility has any of the recalled Medline catheter lab pack kits listed in this recall
  • Match your lot numbers and SKU codes against the FDA recall list
  • Stop using affected kits immediately and contact Medline for replacement or guidance
  • Notify your cardiology or interventional radiology team if your facility uses these products
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.

Sold states
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 count
17902 kits
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
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, Medline SKU DYNJ23532C; 4. ANGIO LEFT HEART PACK, Medline SKU DYNJ40632C; 5. ANGIO DRAPE PACK, Medline SKU DYNJ47952B; 6. ANGIOGRAPHIC PACK, Medline SKU DYNJ57516; 7. CATH LAB PACK, Medline SKU DYNJ58243B; 8. CATH LAB PACK, Medline SKU DYNJ65185; 9. CSU CATH MANIFOLD KIT, Medline SKU VASC1170A; 10. MANIFOLD KIT NO TRANSDUCER, Medline SKU VASC1184A.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1716-2026

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