FDA-Device2026-04-15Class IPROCESSING DEFECT

Medline medical convenience kits recalled for syringe adaptor disconnection risk

OTHERNationwide distributionMedical devices

What this means

Medline has recalled certain medical convenience kits containing NAMIC Angiographic Rotating Adaptor syringes used in cardiac catheterization and other procedures. The syringe adaptor may unwind during use, causing a loose or complete disconnection between the syringe and manifold, which could disrupt patient care.

  • Check if your facility has any of the affected Medline SKU numbers listed in this recall (CDS780138K, DYNJ36478B, DYNJ910458, VASC1081C, or VASC1510)
  • Verify the lot numbers on your kits match those in the recall notice
  • Quarantine affected kits and stop using them immediately
  • Contact Medline or your facility's procurement department for replacement or guidance
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The agency's original wording
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.

Intended for
Adults
Illnesses reported
None reported
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
594 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. HEAD AND NECK CDS-LF, Medline SKU # CDS780138K; 2. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 3. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 4. HEART CATH PACK-LF, Medline SKU # DYNJ36478B; 5. THYROIDECTOMY, Medline SKU # DYNJ910458; 6. LH 3 PORT W/O WASTEBAG, Medline SKU # VASC1081C; 7. LHK, Medline SKU # VASC1510; 8. LHK, Medline SKU # VASC1510.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1721-2026

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