Sentinel Seal 8888571513 (UDI 30884521073269)Recalls & reported problems
Cardinal Health 200, LLC · Sentinel Seal Chest Drainage Unit Dry Suction, Dual Drain · Class 2
All models of Sentinel Seal (5)
Data updated Oct 18, 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 30884521073269), received between Jan 12, 2018 and Jul 29, 2020 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Kinked” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Kinked1
- Suction Problem1
Patient problems
- No Consequences Or Impact To Patient1
- No Patient Involvement1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 29, 2020Suction Problem; Suction Problem
THE CUSTOMER STATED DEVICE IS CONNECTED TO DRAINS WITH SUCTION AT -20 MH2O. THERE WAS PRESENCE OF AIR BUBBLES IN THE BLUE COMPARTMENT WHICH WAS NOT ALLOWING THE SUCTION TO BE ADJUSTED. WHEN CHANGING THE DRAINAGE PACK, THE DRAINS WERE CLAMPED AND THERE WAS NO CHANGE AFTER REMOVING THE CLAMPS.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10341360 ↗MalfunctionJan 12, 2018Kinked; Kinked
THE CUSTOMER STATES THAT THE CHEST DRAINAGE UNIT ARRIVED BROKEN WITH KINKED TUBING.
Patient problems: No Patient Involvement
MAUDE report 7186824 ↗
Other Apparatus, Suction, Operating-Room, Wall Vacuum Powered devices
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- Sentinel Seal 8888571562Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Aqua-Seal 8888571299Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- spineX BONE DUST COLLECTOR S-4500Oto-Med, Inc. · Apparatus, Suction, Operating-Room, Wall Vacuum Powered1 recall0 reports
- Aqua-Seal 8888571406Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- Altitude 8888571370Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 reports
- CRD 65651-517Cardinal Health 200, LLC · APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED1 recall0 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 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- 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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