Medline Industries, LP: Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
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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 Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
- Reason / hazard
- Affected lots may exhibit issues with the silicone seal on Tego Connectors included in kits. Issues include silicone seal doming and silicone seal tearing. These issues may result in an occluded fluid path identified by the inability of the user to inject or withdraw blood product with a syringe. Damaged seals may also result in delay in therapy or fluid leakage, interruption in therapy, exposure to biological contaminants or air infused into the body.
- Classification
- Class II
- Status
- Ongoing
- Distribution / sold at
- US Nationwide distribution.
- Recall initiated
- 2026-01-08
- Code info
- IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162; NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287
- Product quantity
- 516
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Northfield
- State
- IL
- Country
- United States
- Event id
- 98333
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