Cardinal Health chest drainage units recalled for use in infants; adults only
What this means
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.
The agency's original wording
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1203-2026More Cardinal Health recalls
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