Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | January 08, 2026 |
| Reported | March 04, 2026 |
| Recalling firm | Medline Industries, LP |
| Country / region | United States IL |
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.
Affected products
- Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
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