Medline Industries, LP: Medline medical convenience kits, containing NAMIC Angiographic Rotating Adaptor (RA) Control Syringes (Namic RA syringes), labeled as follo
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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.
- Company / brand
- Medline Industries, LP
- Product
- 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.
- Reason / 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.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- 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).
- Recall initiated
- 2026-02-27
- Code info
- Medline SKU # DYNJ63021B, UDI/DI each 10193489833775UDI/DI case 40193489833776, Lot Number: 26AMD887; Medline SKU # DYNJ64297B, UDI/DI each 10198459472992UDI/DI case 40198459472993, Lot Number: 26AMA970; Medline SKU # DYNJ82411, UDI/DI each 10195327193232UDI/DI case 40195327193233, Lot Number: 25IMB049.
- Product quantity
- 20 kits
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98598
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