FDA DevicesClass II
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU ...
Published: March 4, 2026Recall ID: Z-1468-2026Category: 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
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
Affected Products
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
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) 10195327015954 UDI-DI (case) 40195327015955 Kit lots 24IME953 25CMA708 |
| Postal code | 60093-2753 |
| Report date | 20260304 |
| Product type | Devices |
| Product quantity | 150 |
| 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.