[pending] Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALY
Pending LLM rewrite. Source: FDA_DEVICE Z-1463-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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.
The recalled product
- Product
- Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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