NA 2C1145Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00085412075273), received between May 30, 2019 and Apr 30, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

12 other recalls cover devices cleared under the same FDA submission (K791496); 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.

• MalfunctionApr 30, 2026Mechanical Jam

  IT WAS REPORTED THAT A NON-DEHP IV FAT EMULSION ADMINISTRATION SET WAS "FAULTY GRAVITY HYDRATION TUBING SET". THE ISSUE WAS FURTHER DESCRIBED AS "THE TWISTY PART AT THE VERY END THAT SCREWS ONTO THE END OF THE POSITIVE PRESSURE CAP WAS STUCK TOO FAR UP AND WOULDN'T TWIST" AND THE DEVICE COULD NOT BE CONNECTED. THE ISSUE WAS IDENTIFIED DURING SET UP. 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 25052490 ↗
• MalfunctionMay 30, 2019Fluid/Blood Leak; Material Puncture/Hole; Fluid/Blood Leak; Material Puncture/Hole

  IT WAS REPORTED A SMALL HOLE WAS OBSERVED IN A NON-DEHP IV FAT EMULSION ADMINISTRATION SET WHICH RESULTED IN A LEAK OF AN UNSPECIFIED CHEMOTHERAPY MEDICATION. IT WAS FURTHER REPORTED THAT THERE WERE NO NEEDLES USED DURING THE PREPARATION FOR THIS DRUG AND NO NEEDLES THAT WERE NEAR THE PATIENT WHEN ADMINISTERING THE DRUG. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655317 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K791496. One submission often covers many models, so check the product and lot details in each record.

• Z-0626-06 · Dec 15, 2005 · Terminated
  Baxter Non-DEHP Y-Type Catheter Extension Set, product code 2N1191; An Rx sterile, nonpyrogenic fluid pathway, 4.8', 0.6 mL Vol., with male Luer Lock adapter; Baxter Healthcare Cor
• 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-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-1103-05 · Jul 6, 2005 · Terminated
  Baxter Interlink System Y-Type Minivolume Extension Set, product code 1C8689; 6'', 0.33 mL Vol., with male Luer Lock adapter; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S
• Z-0854-05 · Mar 3, 2005 · Terminated
  Baxter Extension Sets with PosiFlow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posi
• Z-0845-05 · Feb 28, 2005 · Terminated
  Baxter ClearLink Intravenous (IV) Solution Sets and Extension Sets that have a ClearLink luer activated valve for IV access, which allows the administration of medications/solutio
• Z-0694-05 · Jan 20, 2005 · Terminated
  Baxter Extension Sets with Posiflow Access Device for IV Access; product codes 2N9051, 2N9052, 2N9053, 2N9054, 2N9055, 2N9057; a single use, sterile fluid pathway devices with Posi
• 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
• 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-0520-03 · Oct 17, 2002 · Terminated
  Baxter 36'' Micro-Volume Extension Set, catalog 2N3347; Baxter Healthcare Corporation, Deerfield, IL 60015
• Z-0519-03 · Oct 17, 2002 · Terminated
  Baxter Microbore 3-Lead Extension Set with 0.22 Micron High Pressure Pediatric Filter, catalog 2N3342; Baxter Healthcare Corporation, Deerfield, IL 60015; 50 units per case
• Z-0521-03 · Oct 17, 2002 · Terminated
  Baxter 60'' Micro-Volume Extension Set, catalog 2N3350; Baxter Healthcare Corporation, Deerfield, IL 60015