Cook G03611Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00827002036116), received between Mar 19, 2022 and Mar 19, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unsealed Device Packaging” (2 reports).

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.

• MalfunctionMar 19, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT A CHECK-FLO STERILITY SLEEVE WAS UNSEALED. WHEN PREPARING FOR A PROCEDURE, THE USER DISCOVERED THAT THE DEVICE'S STERILE SEAL WAS "BROKEN." THE PRODUCT DID NOT CROSS THE STERILE FIELD. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827310 ↗
• MalfunctionMar 19, 2022Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THREE CHECK-FLO STERILITY SLEEVES WERE UNSEALED. WHEN PREPARING FOR A PROCEDURE, THE USER DISCOVERED THAT THE DEVICES' STERILE SEALS WERE "BROKEN." THE PRODUCT DID CROSS THE STERILE FIELD. AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13827178 ↗