Reported Feb 4, 2026 · Ongoing
Chest Drainage Units and Accessories
Cardinal Health 200, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cardinal Health 200, LLC · 3651 Birchwood Dr · Waukegan, IL · 60085-8337
Is this the product you have?
Chest Drainage Units and Accessories
12 of 12 products
| # | Product as published |
|---|---|
| 1 | 8888571562 Cardinal Health Sentinel Seal CDU |
| 2 | 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain |
| 3 | 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector |
| 4 | 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector |
| 5 | 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction |
| 6 | 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain |
| 7 | 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector |
| 8 | 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL |
| 9 | 1814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) |
| 10 | 1180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL |
| 11 | 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL |
| 12 | 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL |
- Lot codes and dates
12 of 12 products
Products covered by this recall # Barcodes Product as published 1 50192253003091101922530030938888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA) 2 50192253003084101922530030868888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA) 3 50192253003077101922530030798888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA) 4 50192253003039101922530030318888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA) 5 50192253003015101922530030178888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA) 6 50192253003060101922530030628888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA) 7 50192253003022101922530030248888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA) 8 50192253002643101922530026458884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA) 9 50192253002308101922530023001814713105 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS) 10 50192253002292101922530022941180571570 OUS¿Only - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA) 11 50192253002650101922530026528884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA) 12 50192253002667101922530026698884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA) - Amount recalled
- 1,169,726 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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