Cardinal Health recalls chest drainage units for adults only; using on infants may cause treatment delays and prolonged hospitalization due to lack of tidaling/bubbling.
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.
Cardinal Health is recalling chest drainage units and accessories that are intended for adults 18 and older. Using these on infants could lead to incorrect treatment assessments, delays in care, and longer hospital stays because the units may not show proper function indicators.
When used on infants, the chest drainage units may not demonstrate tidaling or bubbling, which are key indicators of proper function. This can cause clinicians to misjudge whether the device is working correctly, potentially leading to inadequate treatment, delays in care, and longer hospital stays.
Infants and children using these chest drainage units for medical purposes. Healthcare providers who administer treatment to infants with these devices are at higher risk of improper assessment.
Check for product codes listed in the recall: 8888571562, 8888571513, 8888571489, 8888571370, 8888571299, 8888571406, 8888571315, 8884713100, 1814713105, 1180571570, 8884713308, 8884713900. These units were sold for adults only but may be used on infants.
Identify if your chest drainage unit has one of the listed product codes (e.g., 8888571562) from the recall list.
Ensure the device is only used on patients aged 18 years or older as per the updated instructions.
The recall updates the instructions to clarify that these chest drainage units are intended for adults 18 and older. Using them on infants may cause the device to not show proper function indicators, leading to treatment delays.
Check the product code on your device. If it matches the recalled list, ensure it is only used on patients aged 18 or older. No return or replacement is required as the hazard is about correct use, not a defect.
The recall states that using these units on infants may lead to inadequate treatment, delays in care, and prolonged hospitalization, but it does not specify a risk of serious injury like death.
We’ve drafted a message you can send Cardinal Health to request your refund or repair — edit it as you like.
Subject: Recall Z-1203-2026 — Cardinal Health Cardinal Health Hello, I own a Cardinal Health that is covered by recall Z-1203-2026 from Cardinal Health. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
