INTERLINK 2N3399Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412004983), received between Dec 14, 2021 and Dec 14, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (2 reports).

26 other recalls cover devices cleared under the same FDA submission (K925126); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 14, 2021Contamination; Contamination

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM INJECTION SITES WERE UPSIDE DOWN INSIDE THE PACKAGING AND THEY WERE EXPOSED TO POTENTIAL CONTAMINATION. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003452 ↗
• MalfunctionDec 14, 2021Contamination; Contamination

  IT WAS REPORTED THAT AN UNSPECIFIED QUANTITY OF INTERLINK SYSTEM INJECTION SITES WERE UPSIDE DOWN INSIDE THE PACKAGING AND THEY WERE EXPOSED TO POTENTIAL CONTAMINATION. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13003442 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K925126. One submission often covers many models, so check the product and lot details in each record.

• Z-1269-2013 · Mar 28, 2013 · Terminated
  A) Product Code 2N3371: Non-DEHP Y-Type Catheter Extension Set, 5.7", Vol. 0.8 mL, 2 Injection Sites, Male Luer Lock Adapter, Single use only Product Usage: This device is ind
• Z-0471-2012 · Dec 6, 2011 · Terminated
  Baxter Interlink System Extension Set, 20" (51 cm), Vol. 2.9 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, nonpyrogenic fluid pathway for the administration of sterile
• Z-2837-2011 · Jul 6, 2011 · Terminated
  Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, 6.6(17 cm), Volume 0.8 mL, Injection Site, Male Luer Lock Adapter; an Rx sterile, single use nonpyrogenic fluid pathw
• Z-0634-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Non-DEHP I.V. Catheter Extension Set, product code 2N3384; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.5 mL Vol., with injection site and male Luer
• Z-0640-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8412; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream F
• Z-0648-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.8 mL Vol., with 2 injection sites and male Luer Lo
• Z-0637-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8290; An Rx sterile, nonpyrogenic fluid pathway, 11.0'', 0.86 mL Vol., with 2 injection sites and male Luer Lock ad
• Z-0641-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8462; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 4.2 mL Vol., with 2 injection sites, 0.22 Micron Downstrea
• Z-0638-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8378; An Rx sterile, nonpyrogenic fluid pathway, 9.0'', 0.6 mL Vol., with injection site and male Luer Lock adapter
• 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-0644-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8643; An Rx sterile, nonpyrogenic fluid pathway, 7'', 0.3 mL Vol, with Male Luer Slip T-Connector; Baxter Healthcar
• Z-0629-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Non-DEHP Standard Bore 3-Lead Catheter Extension Set, product code 2N3335; An Rx sterile, nonpyrogenic fluid pathway with 2 Interlink injection sites and a
• Z-0652-06 · Dec 15, 2005 · Terminated
  Baxter Interlink System Minivolume Extension Set, product code 1C8740; An Rx sterile, nonpyrogenic fluid pathway, 16.0'', 1.0 mL Vol., with injection site, 0.22 Micron Downstream F
• Z-1424-05 · Aug 3, 2005 · Terminated
  Baxter Interlink System Non-DEHP Y-Type Catheter Extension Set, product code 2N3371; An Rx sterile, nonpyrogenic fluid pathway, 5.7'', 0.8 mL Vol., with 2 injection sites and a mal
• Z-1102-05 · Jul 6, 2005 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8645; 9'', 0.8 mL Vol., with 2 injection sites and a male Luer Lock adapter; Baxter Healthcare Corporation,

…and 11 more.