Cardinal Health recalled 1,169,726 chest drainage units on December 26, 2025. The recall stems from an update to the instructions for use (IFU) clarifying that the devices are intended for adults only. Using these devices on infants may result in delayed treatment and prolonged hospitalization.
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.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Cardinal Health 200, LLC or your healthcare provider for instructions. Notification method: Letter
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The recall affects several models, including Cardinal Health Sentinel Seal CDU and Thora-Seal devices, with product codes ranging from 8888571562 to 8884713900. These units were distributed globally, including the US, Brazil, Canada, and Mexico.
The IFU update clarifies that these chest drainage units are intended for adults aged 18 and older. When used on infants, the devices may not function properly, potentially leading to inadequate treatment.
Stop using the affected chest drainage units immediately. Contact Cardinal Health 200, LLC or your healthcare provider for further instructions regarding the recall.
For more information, contact Cardinal Health at 1-800-xxxx-xxxx or visit their website at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1203-2026.
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