Medline Industries recalled 33 units of IV Administration Sets on November 26, 2025. The recall follows customer complaints about check valve components potentially becoming stuck. This defect poses a high risk to patient safety and requires immediate action from healthcare providers.
Medline kits contain B. Braun IV Administration Sets and Pump Administration Sets which were recalled due to customer complaints identifying that the check valve components may become stuck in the open or closed positions.
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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The recall affects Medline kits containing B. Braun IV Administration Sets and Pump Administration Sets. The affected SKU is DYNJ63395B, with model numbers UDI/DI 10195327634698 and 40195327634699. Lot numbers include 25HLA435 and 25HLB046.
The check valve components in these IV sets may become stuck in either the open or closed positions. This malfunction could lead to improper administration of fluids or medications, posing a serious health risk to patients.
There have been no reported injuries or deaths associated with this recall. However, the potential for serious complications exists due to the malfunctioning components.
Healthcare providers and patients should immediately stop using the affected devices. Follow the recall instructions provided by the manufacturer and contact Medline Industries or a healthcare provider for further instructions.
For more information, contact Medline Industries, LP. Consumers can visit the FDA's website for additional recall details.
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