ACS CDLA37ERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00191072073242), received between Nov 18, 2019 and Nov 18, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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 16, 2026.

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.

• MalfunctionNov 18, 2019Contamination /Decontamination Problem

  STERILE LAPAROTOMY SUPPLY PACK CONTAINED A CONTAMINATE: HAIR FOUND UNDERNEATH THE STRYROFOAM TRAY. PACK & HAIR RETAINED. HAIR 1 3/4" BROWN. DISCOVERED WHEN TRAY MOVED DURING TABLE SET-UP. SINCE STERILITY OF SURGICAL FIELD WAS IN QUESTION, FIELD DISCARDED AND ANOTHER STERILE FIELD SET-UP DISCOVERED PRIOR TO PATIENT EXPOSURE; NO PATIENT HARM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9334723 ↗