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First Aid Only 363705Recalls & reported problems

Acme United Corporation · CPR LAERDAL POCKET MASK · Class 1

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00738743007085), received between Aug 16, 2023 and Aug 16, 2023 — classified as 1 malfunction.

The most frequently reported specific device problem is “Coagulation in Device or Device Ingredient” (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

Device problems

  • Coagulation in Device or Device Ingredient1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 16, 2023Coagulation in Device or Device Ingredient; Coagulation in Device or Device Ingredient

    IT WAS REPORTED THAT WHILE USING TUBE MICRO K2 EDTA LAV MAP CE THAT THERE WERE CLOTTING/MICRO CLOTS/FIBRIN CLOTS. THIS OCCURRED 10 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHORT DESCRIPTION: SAMPLES COAGULATION WHEN DID THE INCIDENT OCCUR? AFTER USE AFTER SAMPLING, SOME TUBES SHOW COAGULATION AND CLOTTING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17555684 ↗

Other Mouthpiece, Breathing devices

All Mouthpiece, Breathing devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.