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FDA-Device2026-02-04Class IIMISBRANDING

Cardinal Health chest drainage units recalled for use in infants; adults only

Cardinal Health
LABEL MIX UPNationwide distribution

Stop using Cardinal Health chest drainage units on infants

Cardinal Health is updating instructions for multiple chest drainage unit models to clarify they are intended only for adults 18 years and older. When used on infants, these devices may not show proper bubbling or fluid movement, which can make it hard for clinicians to tell if the device is working correctly. This could delay or prevent needed treatment.

  • If you work in a hospital or clinic, review the updated instructions for your Cardinal Health chest drainage units.
  • Do not use these devices on infants under 18 years old.
  • Contact your Cardinal Health representative or the FDA if you have questions about which devices are affected.
Hazard

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.

Sold states
Worldwide distribution - US Nationwide and the countries of Brazil, Canada, Chile, Colombia, Dominican Republic, and Mexico.
Affected count
1,169,726 units
Manufactured in
3651 Birchwood Dr, N/A, Waukegan, IL, United States
Products
Chest Drainage Units and Accessories: Product Code Description 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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1203-2026

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