INTERLINK 2N3327Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00085412004655), received between Jun 4, 2025 and Jun 4, 2025 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Split, Cut or Torn” (1 report).

8 other recalls cover devices cleared under the same FDA submission (K921899); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 4, 2025Material Split, Cut or Torn; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE TUBING OF TWO (2) INTERLINK NON-DEHP T-CONNECTOR EXTENSION SETS SLICED IN HALF WHEN THE BLUE OCCLUSION CLAMP WAS SLID OVER THE TUBING. WHEN THE SLIDE CLAMP WAS ACTIVATED TO OCCLUDE THE SET, THE DEVICE WAS SEVERED. THIS OCCURRED TWICE ON THE SAME 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 22144234 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K921899. One submission often covers many models, so check the product and lot details in each record.

• Z-0653-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Continu-Flo Solution Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0078; An Rx sterile, nonpyrog
• Z-0654-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Buretrol Solution Set with Large Bore 3-Way Stopcock with Rotating Male Luer Lock Extension Set and Minivolume Extension Set, product code 3C0108; An Rx ste
• Z-0630-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System T-Connector Extension Set, product code 2N3343; An Rx sterile, nonpyrogenic fluid pathway, 7.0'', 1.0 mL Vol., with 1 Interlink T-connector injection sites
• Z-0646-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Extension Set with Standard Bore 4-Way Stopcock Manifold Extension Set and Minivolume Extension Set, product code 3C0071; An Rx sterile, nonpyrogenic fluid
• Z-0656-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Buretrol Solution Set with Large Bore 4-Way Stopcock with Rotating Male Luer Lock Extension Set and Extension Set, product code 3C0172; An Rx sterile, nonp
• Z-0643-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8590; An Rx sterile, nonpyrogenic fluid pathway, 22'', 0.9 mL Vol, with injection site and Stationary Swivel Lock T
• Z-0518-03 · Oct 17, 2002 · Terminated
  Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3333; Baxter Healthcare Corporation, Deerfield, IL 60015; 200
• Z-0517-03 · Oct 17, 2002 · Terminated
  Baxter Interlink System Microbore T-Connector Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3332; Baxter Healthcare Corporation, Deerfield, IL 60015; 200