Bard Safe-T-Centesis 6 Fr Catheter Drainage Tray recalled for faulty safety indicator
Stop using Bard Safe-T-Centesis drainage trays
Bard Peripheral Vascular Inc. is recalling Safe-T-Centesis 6 Fr Catheter Drainage Trays because the safety indicator on the catheter may show the wrong position—displaying "sharp" when the catheter is actually "blunt." This could lead medical staff to believe the catheter hasn't entered the body cavity when it actually has, potentially causing discomfort, treatment delays, or injury to organs or blood vessels.
- Stop using affected trays immediately (check lot numbers ending in 0001623320 or 0001623069, expiration 11/2027).
- Contact your hospital or clinic's medical device safety officer or supply chain team.
- Return unused trays to Bard Peripheral Vascular Inc. or your supplier.
- Review recent procedures with this device and alert your clinical team.
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0887-2026Don't want to check this manually?
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