Safety Enforcement Notice

Chest Drainage Units and Accessories: Product CodeDescription 1. 8888571562Cardinal Health Sentinel Seal CDU 2. 8888571513Cardinal Health Sentinel Seal CDU, Dual Drain 3. 8888571489Cardinal Health Sentinel Seal CDU, with Easy Change Connector 4. 8888571370Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 5. 8888571299Cardinal Health Aqua-Seal CDU, Wet Suction 6. 8888571406Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 7. 8888571315Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 8. 8884713100Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 9. 1814713105OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 10. 1180571570OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 11. 8884713308Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 12. 8884713900Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL

Issued for products by Cardinal Health 200, LLC

Recall Event Details

Primary ID / Event Code: Z-1203-2026
Classification Code: All units affected by IFU update. UDI-DI: 1. 8888571562 Cardinal Health Sentinel Seal CDU 50192253003091 (CS) 10192253003093 (EA) 2. 8888571513 Cardinal Health Sentinel Seal CDU, Dual Drain 50192253003084 (CS) 10192253003086 (EA) 3. 8888571489 Cardinal Health Sentinel Seal CDU, with Easy Change Connector 50192253003077 (CS) 10192253003079 (EA) 4. 8888571370 Cardinal Health Altitude CDU, Dry Suction, with Easy Change Connector 50192253003039 (CS) 10192253003031 (EA) 5. 8888571299 Cardinal Health Aqua-Seal CDU, Wet Suction 50192253003015 (CS) 10192253003017 (EA) 6. 8888571406 Cardinal Health Aqua-Seal CDU, Wet Suction, Dual Drain 50192253003060 (CS) 10192253003062 (EA) 7. 8888571315 Cardinal Health Aqua-Seal CDU, Wet Suction, with Easy Change Connector 50192253003022 (CS) 10192253003024 (EA) 8. 8884713100 Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL 50192253002643 (CS) 10192253002645 (EA) 9. 1814713105 OUSOnly - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only) 50192253002308 (CS) 10192253002300 (CS) 10. 1180571570 OUSOnly - Cardinal Health Thora-Seal CDU, Two Chamber System, 2600 mL 50192253002292 (CS) 10192253002294 (EA) 11. 8884713308 Cardinal Health Thora-Seal CDU, Three Chamber System, 2500 mL 50192253002650 (CS) 10192253002652 (EA) 12. 8884713900 Cardinal Health Thora-Seal Replacement Collection Chamber, 2500 mL 50192253002667 (CS) 10192253002669 (EA)
Manufacturer: Cardinal Health 200, LLC
Reported Date: August 9, 2026