BD GasPak™ EZ Anaerobe Container System Sachets with Indicator 260001Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382902600016), received between Jun 18, 2021 and Aug 29, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination of Device Ingredient or Reagent” (2 reports).

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR, 20 SACHETS DON'T PRODUCE AN ANEROBIC CONDITION. NO PATIENT IMPACT REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE SACHETS DON'T PRODUCE ANAEROBIC CONDITION. THE CUSTOMER PUT ONE SACHET WITH INDICATOR INTO A JAR, AFTER A NIGHT THEY WAS NOTICE THE INDICATOR STAY BLUE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17647305 ↗
• MalfunctionJun 2, 2022Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR WERE CONTAMINATED. THERE WAS NO REPORT OF CONFIRMATORY TESTING. NO PATIENT IMPACT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14580232 ↗
• MalfunctionJun 18, 2021Contamination of Device Ingredient or Reagent; Contamination of Device Ingredient or Reagent

  IT WAS REPORTED THAT WHILE USING 6 BD GASPAK¿ EZ ANAEROBE CONTAINER SYSTEM WITH INDICATOR MOLD CONTAMINATION WAS OBSERVED BY THE LABORATORY PERSONNEL. THERE WAS NO INDICATION THAT RESULTS WERE REPORTED OUT AND THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IN TERMS OF THE SACHETS THEY APPEAR TO BE CONTAMINATED PRIOR TO BEING USED. THEY LOOK MOULDY TO ME FROM THE IMAGES & THE CUSTOMER SAID THEY APPEARED TO BE CONTAMINATED PRIOR TO USE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12025877 ↗