BD GasPak™ EZ Anaerobe Gas Generating Pouch System with Indicator 260683Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 30382902606834), received between May 7, 2022 and Oct 17, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USAGE OF BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR THEY ENCOUNTERED A PERFORMANCE ISSUE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTED: IT WAS REPORTED BY CUSTOMER THAT GASPAK 260683 ANAEROBIC CONDITIONS NOT MAINTAINING FOR 6 DAYS. GASPAK 260683 PERFORMANCE PAST 2 DAYS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17951411 ↗
• MalfunctionSep 28, 2023Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING THE BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR THAT THERE WAS CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THERE IS POSSIBLE CONTAMINATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17830944 ↗
• MalfunctionJun 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH SYSTEM WITH INDICATOR AN ATYPICAL REACTION 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: " ANAEROBIC INDICATORS ARE CHECKED 4-24HOURS TO ENSURE ANAEROBIC CONDITIONS ARE ACHIEVED. HOWEVER IT HAS BEEN NOTED THAT ANAEROBIC CONDITIONS WERE ACHIEVED ON THIS CHECK AND SOMEWHERE AFTER THE 24HOUR CHECK AND THE FINAL READ THE INDICATOR SHOWS THAT ANAEROBIC CONDITIONS WERE NOT MET. "

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14877511 ↗
• MalfunctionMay 7, 2022Contamination; Contamination

  IT WAS REPORTED THAT WHILE USING BD GASPAK¿ EZ ANAEROBE GAS GENERATING POUCH 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: CUSTOMER REPORTS A LACK OF GROWTH WHEN USING GASPAK 260683. CUSTOMER ADDITIONALLY REPORTS THAT AFTER 2 DAYS OF INCUBATION THE SACHETS DISPLAY BLACK DOTS SIMILAR TO MOLD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14322755 ↗