Cook G02327Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002023277), received between Dec 12, 2024 and Dec 12, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Unsealed Device Packaging” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Aug 16, 2022Open, Classified

   Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

   Z-1844-2022 · Root cause: Under Investigation by firm · FDA record ↗

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.

• MalfunctionDec 12, 2024Unsealed Device Packaging; Unsealed Device Packaging

  IT WAS REPORTED THAT THE SEAL OF A DRAINAGE BAG CONNECTOR CONNECTING TUBE WAS MISSING. NO DAMAGE TO THE SHIPPING CONTAINER WAS OBSERVED. THE MISSING SEAL WAS DISCOVERED PRIOR TO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20916002 ↗