Acu-Life PC12/HKPC12/PC12WERecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00079573009161), received between Sep 1, 2020 and Sep 1, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Product Quality 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 18, 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.

• MalfunctionSep 1, 2020Product Quality Problem; Product Quality Problem

  APOTHECARY PRODUCTS LLC. RECEIVED A REPORT FROM MEDWATCH (REPORT NUMBER MW5095448 [MDR REPORT KEY (B)(4)]) : WHEN SPEAKING WITH A GROUP OF NURSING STAFF ABOUT OUR CURRENT PRACTICES OF CRUSHING MEDICATION TABLETS, IN RESPONSE TO AN (B)(4) NEWSLETTER ABOUT AN ISSUE WITH A PLASTIC ENTERAL SYRINGE PRODUCT, IT WAS BROUGHT TO MY ATTENTION AN ISSUE WITH A DIFFERENT PRODUCT WE USE FOR PILL CRUSHING. CURRENTLY, A PRODUCT WE CARRY IS THE HEALTHSMART PILL CRUSHER/PULVERIZER. SEVERAL NURSES HAVE BROUGHT IT TO MY ATTENTION THAT IN THE PAST, WHEN USING THE PRODUCT TO CRUSH TABLETS, THE PLASTIC BOTTOM HAS SHATTERED/BROKEN WHILE IN USE. THIS COULD HAVE LED TO SMALL PIECES OF PLASTIC BEING ADMINISTERED TO PATIENTS IF NURSING STAFF WAS NOT CAREFUL. WE ARE CURRENTLY IN THE PROCESS OF REMOVING THESE PRODUCTS FROM ALL OF OUR UNITS TO PREVENT ANY BREAKAGES IN THE FUTURE. WE WILL INSTEAD UTILIZE OUR OTHER PRODUCT, SILENT KNIGHT, IN THE FUTURE. (B)(4).

  Patient problems: Not Applicable

  MAUDE report 10479652 ↗