CARDINAL HEALTH BB3000LFBRecalls & reported problems
Cardinal Health 200, LLC · Breathing Bag · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 50885380208421), received between Aug 29, 2026 and Aug 29, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Incomplete or Inadequate Connection” (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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Incomplete or Inadequate Connection2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 29, 2026Incomplete or Inadequate Connection
Patient problems: Insufficient Information
MAUDE report 50509952 ↗MalfunctionAug 29, 2026Incomplete or Inadequate Connection
Patient problems: Insufficient Information
MAUDE report 50509834 ↗
Other BAG, RESERVOIR devices
- VentStar Bag Set (P) 110 MP00384Drägerwerk AG & Co. KGaA · Bag, Reservoir2 recalls0 reports
- VentStar Bag Set (N) 110 MP00383Drägerwerk AG & Co. KGaA · Bag, Reservoir1 recall0 reports
- Portex 101/870/070CZIcu Medical, Inc. · BAG, RESERVOIR28 reports
- WalkMed® 204821Walkmed Technologies, LLC · Bag, Reservoir4 reports
- Portex C45031768D-NLIcu Medical, Inc. · BAG, RESERVOIR3 reports
- Portex C37201370JIcu Medical, Inc. · BAG, RESERVOIR2 reports
- Portex C49201668D-NLIcu Medical, Inc. · BAG, RESERVOIR2 reports
- WalkMed® 204822Walkmed Technologies, LLC · Bag, Reservoir1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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