Device product
Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follows: 1. SHOULDER ARTHROSCOPY PACK, Medline SKU # DYNJ30880M; 2. EXTREMITY PACK, Medline SKU # DYNJ64295A.
Z-1730-2026
Product summary
- Event
- Event 98598
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 82 kits
- Official record key
device-enforcement:Z-1730-2026
Official wording
Reason: 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.
Code information: 1. Medline SKU # DYNJ30880M, UDI/DI each 10198459446207, UDI/DI case 40198459446208, Lot Number: 25LMJ532; 2. Medline SKU # DYNJ64295A, UDI/DI each 10193489353853, UDI/DI case 40193489353854, Lot Number: 24KMI274.
Distribution pattern: 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).
Derived failure modes
-
Unknown
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.