Bard Peripheral Vascular recalled 1,240 Safe-T-Centesis Catheter Drainage Trays due to safety indicator defects. The recall affects products distributed nationwide since November 6, 2025. The defect may cause serious injuries during use in medical procedures.
Acute drainage catheters, indicated for use in removing fluid during acute drainage/aspiration procedure, manufactured with safety indicators that erroneously show catheter in sharp position when catheter is in blunt position, which may lead users to believe device is not yet in pleural or peritoneal space when it is, may cause discomfort, delay to treatment, injury to internal organs or vessels.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Bard Peripheral Vascular Inc or your healthcare provider for instructions. Notification method: N/A
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The recall covers Safe-T-Centesis 6 Fr Catheter Drainage Tray, REF: PIG1260T. It includes lot numbers (01)10885403108365(17)271130(10)0001623320 and (01)10885403108365(17)271130(10)0001623069. These products were distributed in California, Minnesota, Indiana, Michigan, and Louisiana.
The catheters have faulty safety indicators, which may show a sharp position when the catheter is actually in a blunt position. This misrepresentation can lead to users believing the device is not in the pleural or peritoneal space, increasing the risk of discomfort and internal injuries.
There are no reported injuries or deaths associated with this recall, but the potential for serious injury exists due to the nature of the defect.
Stop using the affected catheters immediately. Contact Bard Peripheral Vascular Inc or your healthcare provider for further instructions.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0887-2026.
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