C.R. Bard Inc. is recalling approximately 175,158 Lubri-Sil and Bardex Foley Catheters due to a defect where the catheter's drainage tube may be obstructed. This blockage can prevent the bladder from draining urine properly, which can lead to severe medical complications. The recall affects several models including the Bardex Lubri-Sil I.C. 400-series, SureStep Foley Tray Systems, and Bard Silver Lubri-Sil Foley Trays distributed to hospitals and medical providers worldwide. While no injuries have been reported in the current data, a blockage of this type can result in significant abdominal pain and kidney issues.
The tubing within the catheter may be blocked, making it impossible for the device to drain urine from the bladder. This obstruction can cause pelvic or abdominal pain and may lead to serious clinical conditions such as acute kidney injury, bladder dysfunction, or hydronephrosis (swelling of the kidneys).
Recall #: Z-2462-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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