ClearanceBrief
Recall Z-2985-2026 ยท MPB Catheter, Hemodialysis, Non-Implanted

Bard Access Systems, Inc.

DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625200; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625240; DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625300; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626120; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626150; DuoGlide Sho

DateSep 11, 2026 (initiated Aug 10, 2026)
StatusOpen, Classified
Reasonthis is a downstream recall of class I recall RES 98777
Root causeMaterial/Component Contamination
ActionOn 8/10/2026, recall notices were mailed or emailed to customers and distributors who were asked to do the following: 1) Do not use the Sodium chloride ampules contained within the affected products. The sodium chloride ampule is the only impacted component within the tray and all remaining components can continue to be used. 2) Secure an alternative local Sodium chloride prior to entering the procedural environment. 3) Upon opening the tray, remove and destroy the ampules within a controlled and sterile environment to maintain the sterility of the remaining components within the tray. 4)
Quantity22,980
DistributionUS: FL, IL, OH, VA, MD, TX, WI, GA, TN, IN, SC, NC, MI, PA, OR, OK, AZ, MS, NJ, AL, CA, CO, MA, NV, ID, MO, LA, WA, KY, IA, NH, NY, KS, HI, NE, MN, MT, WY, AR, RI, WV, UT, PR, DE, CT, ME, DC, ND, NM, SD
FDA recordOpen on fda.gov

510(k) clearances named in this recall

K030268NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS
C.R. Bard, Inc., Jul 30, 2003
K090102NIAGARA, NIAGARA SLIM-CATH, AND BREVIA SHORT-TERM CURVED EXTENSION HEMODIALYSIS CATHETERS
C.R. Bard, Inc., Feb 12, 2009