Salem Sump 8888268060 (UDI 10884521007741)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10884521007741), received between Jun 3, 2019 and Mar 23, 2020 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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 23, 2020Suction Failure; Suction Failure

  THE CUSTOMER REPORTED THAT THE SALEM SUMP WAS NOT SUCTIONING WELL. THE NURSE IRRIGATED IT WITH STERILE WATER AND FOUND A LEAK NEAR THE AIR PORT. THERE WAS NO PATIENT INJURY. ADDITIONAL INFORMATION PROVIDED STATED THAT THE TUBING WAS NOT FUNCTIONING AT ALL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9865779 ↗
• MalfunctionJun 3, 2019Material Separation; Material Separation

  THE CUSTOMER REPORTS THAT THEY OPENED THE STERILE PACKAGE AND WHILE UNCOILING THE TUBING FOUR INCHES BROKE OFF OF THE BOTTOM OF THE SALEM SUMP.

  Patient problems: No Patient Involvement

  MAUDE report 8662601 ↗