Medline Industries Class II Recall - Tego Connector Silicone Seal Defect
Summary
The FDA has initiated a Class II recall for Medline Industries' Convenience kits containing Tego Connectors (SKU DYNDC3167) due to issues with the silicone seal. The defect, including doming and tearing, can lead to an occluded fluid path, preventing proper blood product injection or withdrawal. The recall affects nationwide distribution in the US.
What changed
The FDA has issued a Class II recall for Medline Industries' Convenience kits containing Tego Connectors (SKU DYNDC3167). The affected lots have defects in the silicone seal, such as doming and tearing, which can cause an occluded fluid path. This occlusion prevents users from injecting or withdrawing blood product with a syringe, posing a risk to patient care.
Healthcare providers and facilities that have received these kits should immediately stop using them and follow Medline's instructions for product return or disposition. The recall is ongoing and affects nationwide distribution within the US. Compliance with the recall procedures is critical to mitigate patient safety risks.
What to do next
- Cease use of affected Medline Convenience kits containing Tego Connectors.
- Follow Medline Industries' specific instructions for product return or disposition.
- Document compliance with recall procedures.
Source document (simplified)
Medline Industries, LP
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1468-2026 · 20260304 · Ongoing
Product
Convenience kits containing Tego Connectors Medline DIALYSIS DRSNG CHNG SKU DYNDC3167
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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