Medline Industries, LP
Device Recalls (Class II)
Class II
Z-1464-2026
·
20260304
·
Ongoing
Product
Medline Kits containing Tego Connectors Medline DIALYSIS ON/OFF KIT SKU EBSI1746
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....
Distribution
US Nationwide distribution.
Source: openFDA Enforcement API