Medline Industries recalls 2,894 Aqua-Seal Chest Drainage Units from Cardinal Health after updating IFUs to specify adult patients 18 years and older. The devices were distributed worldwide, including California, Chile and Panama. The update clarifies intended patient population and requires action from healthcare providers to stop use until further notice.
The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Medline Industries, LP or your healthcare provider for instructions. Notification method: Letter
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Chest drainage units are used in surgical settings to remove air and fluids from the chest. They support post-operative care in cardiac procedures.
The recall centers on clarified adult-only target population in the device IFUs. This affects labeling and may influence patient selection and usage.
This recall is not described as part of a broader industry pattern in the notice.
Facilities must stop use for affected units and verify alignment with updated IFUs. No injuries reported in the notice, but operational disruption and potential documentation burden exist.
FDA recall page linked in enforcement report and Medline recall communications
Processing and remediation timelines vary by facility; 4-8 weeks is a common framework
Keep copies of recall notices, model/lot numbers, correspondence with Medline and facility records
Product: Aqua-Seal Chest Drainage Unit. Brand: Cardinal Health via Medline Industries, LP. Models: DYNJ902487A; DYNJ908126; DYNJ910851. UDI-DI: 10193489496635. Lot numbers include 22KMG297, 22FMA481, 21IMG797, 21HMG569, 21HMB801. Quantity: 2894 units. Distribution: Worldwide, including United States (California), Chile, Panama.
No injuries or incidents are described in the provided notice.
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