Medline Kits with Tego Connectors Recalled Due to Silicone Seal Defects
Medline Industries, LP is recalling specific Medline Kits containing Tego Connectors because the silicone seals may dome or tear, potentially causing fluid leakage or blocked paths.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The product is a medical device with a high-risk hazard (potential for biological contamination or air infusion) where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling certain Medline Kits containing Tego Connectors, including the Medline IR Pack (SKU DYNJ67205C) and Medline NO CATHETER DIALYSIS INSERTION (SKU CVI5200).
The silicone seals on the Tego Connectors in these kits may exhibit doming or tearing. These defects can lead to an occluded fluid path, making it difficult for users to inject or withdraw blood products with a syringe.
Additionally, damaged seals may cause fluid leakage, interruptions in therapy, delays in therapy, or the introduction of air or biological contaminants into the body.
The recalled product
- Product
- Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
- Manufacturer
- Medline Industries, LP
- Affected units
- 516
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Medline Industries, LP under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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