Medline Recalls Tego Connector Kits Due to Seal Defect
Summary
Medline Industries, LP is recalling Tego Connector kits (Class II recall) due to potential issues with the silicone seal, which could lead to an occluded fluid path. The recall affects nationwide distribution in the US. The FDA has assigned this recall the identifier Z-1467-2026.
What changed
Medline Industries, LP has initiated a Class II recall for Tego Connector kits, identified by FDA recall number Z-1467-2026, due to a defect in the silicone seal. Affected lots may exhibit silicone seal doming or tearing, potentially resulting in an occluded fluid path that prevents the user from injecting or withdrawing blood product with a syringe. This recall impacts nationwide distribution within the United States.
Healthcare providers and medical device makers using these kits should be aware of this recall and take appropriate action to identify and remove affected products from inventory. While the document does not specify a compliance deadline, prompt action is necessary to mitigate patient safety risks associated with compromised fluid paths. Non-compliance with recall procedures can lead to further regulatory action by the FDA.
What to do next
- Identify and remove affected Tego Connector kits from inventory
- Review internal procedures for handling device recalls
- Report any adverse events related to the recalled product
Source document (simplified)
Medline Industries, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1467-2026 · 20260304 · Ongoing
Product
Convenience kits containing Tego Connectors: Medline DIALYSIS DRESSING CHANGE SKU EBSI1498 Medline DIALYSIS DRESSING CHANGE KIT SKU EBSI1107 EBSI1596 EBSI1781 EBSI1812 Centurion DIALY...
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
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