ONE-LINK 7N8370KRecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00085412613505), received between Mar 17, 2021 and Mar 16, 2023 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Disconnection” (5 reports).

1 FDA recall record name this device's identifier.

1 other recall 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.

Recalls naming this device

1. Dec 21, 2020Class IITerminated

   There were customer reports of separation between the tubing and Male Luer Lock Adaptor.

   Z-1102-2021 · Root cause: Process design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 16, 2023Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  IT WAS REPORTED THAT THE STERILE PACKAGING OF THREE (3) ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS WERE DAMAGED. THE ISSUE WAS IDENTIFIED BEFORE PATIENT USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16561567 ↗
• MalfunctionOct 15, 2021Disconnection; Disconnection

  IT WAS REPORTED A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET SEPARATED. IT WAS FURTHER REPORTED THAT DURING AN UNSPECIFIED PATIENT INFUSION, THE ONE-LINK CAME OFF THE "LUER STEM". THE SET WAS CHANGED OUT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643187 ↗
• MalfunctionOct 15, 2021Disconnection; Disconnection

  IT WAS REPORTED A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET SEPARATED. IT WAS FURTHER REPORTED THAT DURING AN UNSPECIFIED PATIENT INFUSION, THE ONE-LINK CAME OFF THE "LUER STEM". THE SET WAS CHANGED OUT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12643070 ↗
• MalfunctionAug 5, 2021Disconnection; Disconnection

  IT WAS REPORTED THAT A ONE LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET FELL APART WHILE ATTACHED TO THE PATIENTS PORT-A-CATH. THIS WAS OBSERVED DURING PATIENT INFUSION OF MGSO4 (MAGNESIUM SULFATE) PRIOR TO CHEMOTHERAPY. THE LINE WAS CLAMPED, THE INFUSION WAS STOPPED, AND THE EXTENSION SET WAS REPLACED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12282976 ↗
• MalfunctionMar 17, 2021Disconnection; Disconnection

  IT WAS REPORTED TWO (2) ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SETS SEPARATED. THE EVENT WAS FURTHER DESCRIBED AS WHEN THE DEVICE WAS CONNECTED TO A UNKNOWN SYRINGE AND UNKNOWN TUBING SET, THE "BIFUSE SEPARATED AT THE ONE-LINK CAP". THE EVENT OCCURRED WHEN CONNECTED TO A PATIENT. 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 11509536 ↗
• MalfunctionMar 17, 2021Disconnection; Disconnection

  IT WAS REPORTED A ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET SEPARATED. THE EVENT WAS FURTHER DESCRIBED AS WHEN THE DEVICE WAS CONNECTED TO A UNKNOWN SYRINGE AND UNKNOWN TUBING SET, THE "BIFUSE SEPARATED AT THE ONE-LINK CAP". THE EVENT OCCURRED WHEN CONNECTED TO A PATIENT. 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 11509535 ↗

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-0132-2016 · May 21, 2015 · Terminated
  ONE-LINK NON-DEHP Y-TYPE MICROBORE CATHETER EXTENSION SET NEEDLE-FREE IV CONNECTOR WITH NEUTRAL FLUID DISPLACEMENT