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Cook G05267Recalls & reported problems

Cook Incorporated · Peritoneal Lavage Set · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002052673), received between Dec 17, 2018 and Dec 17, 2018 — classified as 1 malfunction.

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

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

Device problems

  • Fluid/Blood Leak1
  • Material Puncture/Hole1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionDec 17, 2018Fluid/Blood Leak; Material Puncture/Hole

    IT WAS REPORTED THAT DURING THE PROCEDURE THE PERITONEAL LAVAGE CATHETER WAS LEAKING ON THE SURFACE OF THE ABDOMEN. A CRACK/TEAR WAS FOUND AT THE ROOT OF THE CATHETER. IT WAS FURTHER NOTED THAT THE CATHETER HAD A HOLE NEAR THE HUB. THE CATHETER WAS REPLACED WITH ANOTHER CATHETER. NO OTHER INFORMATION WAS MADE AVAILABLE.

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 8171793 ↗

Other CATHETER, PERITONEAL devices

All CATHETER, PERITONEAL devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.