FDAClass IIMarch 4, 2026

Medline Kits containing Tego Connectors: Medline IR recall

Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200

Why was Medline Kits containing Tego Connectors: Medline IR recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

IR PACK UDI-DI (ea) 10195327621780 UDI-DI (case) 40195327621781 Kit lots 24BBP627 24DBO029 24FBI148 24JBA858 24KBD925 24LBG978 25ABQ002 25EBV162; NO CATHETER DIALYSIS INSERTION UDI-DI (ea) 10195327675219 UDI-DI (case) 40195327675210 Kit Lots 24EBM915 24GBC287

Product
Medline Kits containing Tego Connectors: Medline IR Pack, SKU DYNJ67205C Medline NO CATHETER DIALYSIS INSERTION, SKU CVI5200
Recalling firm
Medline Industries, LP
Quantity
516
Distribution
US Nationwide distribution.
Recall date
March 4, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls