FDA DevicesClass II
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI17...
Published: March 4, 2026Recall ID: Z-1464-2026Category: devicesCountry: US
Reason for Recall / 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.
Product Description & Identification
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Affected Products
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
Additional Source Details
| Field | Value |
|---|---|
| City | Northfield |
| State | IL |
| Event id | 98333 |
| Address 1 | 3 Lakes Dr |
| Address 2 | N/A |
| Code info | UDI-DI (ea) 10653160373582 UDI-DI (case) 00653160373585 Kit lots 2024051380 2024052080 2024052180 2024052280 2024071580 2025061790 2025072990 |
| Postal code | 60093-2753 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 2020 |
| Reason for recall | 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. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260108 |
| Initial firm notification | Letter |
| Center classification date | 20260224 |
Overview
- Recalling FirmMedline Industries, LP
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution.