ACS CDMK10JRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00191072057679), received between Jul 12, 2019 and Dec 5, 2019 — classified as 2 malfunctions.

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. 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.

• MalfunctionDec 5, 2019Material Puncture/Hole

  HOLE IN BOTTOM OF BASIN WRAPPER THAT IS LOCATED INSIDE THE STERILE PACK. CAUGHT PRIOR TO ANY BREAK IN ASEPTIC TECHNIQUE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9415679 ↗
• MalfunctionJul 12, 2019Contamination /Decontamination Problem

  STERILITY ISSUE W/ STERILE SURGICAL PACK. HAIR FOUND ON "BANDAGE, ESMARK 6"X12' LAT FREE" CONTAINED WITHIN STERILE SURGICAL SUPPLY PACK. DISCOVERED BY SCRUB PERSON WHILE FINISHING STERILE SET-UP OF ONE-OF-THREE TABLE. OUTCOME WAS TWO OF THE THREE STERILE SET-UPS HAD TO BE REPLACED, 5 STERILE INSTRUMENT TRAYS, AND STERILE SUPPLIES CONTAINED ON TWO OF THE THREE STERILE TABLES. CONTAMINATION DISCOVERED AND CONTAINED PRIOR TO PATIENT USE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8784737 ↗