ONE-LINK 7N8376KRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00085412599601), received between Jul 23, 2018 and Feb 10, 2026 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

2 other recalls cover devices cleared under the same FDA submission (K132734); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT AN ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET LEAKED DURING PATIENT INFUSION. THE ISSUE WAS FURTHER DESCRIBED AS, "THE TOP TUBE WAS NOT CONNECTED TO THE Y-TUBE CONNECTOR". THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24306100 ↗
• MalfunctionFeb 10, 2026Fluid/Blood Leak; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TUBING OF ONE-LINK NON-DEHP Y-TYPE STANDARD BORE CATHETER EXTENSION SET SEPARATED FROM THE Y-JUNCTION WHICH RESULTED IN A FLUID LEAK. THIS ISSUE WAS DESCRIBED AS ¿LEAK DUE TO CRACK AT BASE OF THE Y-CONNECTOR¿ AND ¿ONE TUBE WAS NOT ACCURATELY CONNECTED/FUSED TO THE Y-CONNECTION¿. THIS EVENT OCCURRED PRIOR TO PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24304063 ↗
• MalfunctionDec 18, 2018No Flow; No Flow

  IT WAS REPORTED THAT A ONE-LINK Y-TYPE STANDARD BORE CATHETER EXTENSION SET WOULD NOT FLUSH. THIS OCCURRED DURING AN UNSPECIFIED PROCESS STEP. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 8177030 ↗
• MalfunctionJul 23, 2018Disconnection; Disconnection

  IT WAS REPORTED THAT THE END CAPS OF A ONE-LINK Y-TYPE EXTENSION SET WERE FALLING OFF. THIS ISSUE WAS DISCOVERED WHEN THE PACKAGING WAS BEING OPENED AND PRIOR TO USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Patient Involvement

  MAUDE report 7712685 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K132734. One submission often covers many models, so check the product and lot details in each record.

• Z-1102-2021 · Dec 21, 2020 · Terminated
  Baxter ONE-LINK Non-DEHP Y-Type Microbore Catheter Extension Set, Bonded Needle-free IV Connector, Neutral Fluid Displacement, 5.7 " (14 cm), REF 7N8370K - Product Usage: intended
• Z-0132-2016 · May 21, 2015 · Terminated
  ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT