Thora-Seal 8884713100Recalls & reported problems
Cardinal Health 200, LLC · Thora-Seal Basic Chest Drainage Unit One Chamber 2000 mL · Class 2
All models of Thora-Seal (4)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
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.
Recalls naming this device
- Dec 26, 2025Class IIOpen, Classified
The firm is updating the IFU to clarify the intended patient population for the identified chest drainage units and accessories as adults, 18 years and older. When used on infants, the CDU may not demonstrate tidaling/bubbling, which may confound the clinician's assessment of device functionality and lead to inadequate/inappropriate treatment/therapy, delay to treatment/therapy, and prolonged hospitalization.
Z-1203-2026 · Root cause: Error in labeling · Recall details · FDA record ↗
Other BOTTLE, COLLECTION, VACUUM devices
- OASIS 3600-100Atrium Medical Corporation · Bottle, Collection, Vacuum3 recalls1 death175 reports
- OCEAN 2002-000Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM3 recalls44 reports
- EXPRESS 16400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall110 reports
- EXPRESS 4000-100NAtrium Medical Corporation · Bottle, Collection, Vacuum2 recalls30 reports
- OCEAN 2002-400Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM2 recalls18 reports
- OASIS 3612-100Atrium Medical Corporation · Bottle, Collection, Vacuum1 recall18 reports
- Medline DYNDSCL1500Medline Industries, Inc. · BOTTLE, COLLECTION, VACUUM1 recall13 reports
- PNEUMOSTAT 16100Atrium Medical Corporation · BOTTLE, COLLECTION, VACUUM1 recall3 deaths12 reports
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
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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