FDA has not published a risk classification for this recall yet.
- Recall #:
- 98228
- Lot/product 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 OUS¿Only - Cardinal Health Thora-Seal Basic CDU, One Chamber, 2000 mL (Bottle only)
50192253002308 (CS)
10192253002300 (CS)
10. 1180571570 OUS¿Only - 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)
- Recalling firm:
- Cardinal Health 200, LLC