Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. LAPAROSCOPIC HERNIORRHAPHY DSC, Medline SKU # DYNJ63021B; 2. LAP PACK, Medline SKU # DYNJ64297B; 3. MINOR PROCEDURE PACK, Medline SKU # DYNJ82411.
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.
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).
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1722-2026