Device recall
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 Short-Term Curved Extension Dialysis Catheter, REF: 5626200; DuoGlide Short-Term Curved Extension Dialysis Catheter, REF: 5626240; Niagara Dual-Lumen Short-Term Curved Extension Dialysis Catheter, REF: 5766200
- Recall number
- Z-2985-2026
- Event id
- 99534
- Status
- Ongoing
- FDA classification
- Class I
- Recalling firm
- Bard Access Systems, Inc.
- Report date
- Sep 23, 2026
- Posted
- Sep 11, 2026
- Initiated
- Aug 10, 2026
- Center classification date
- Sep 11, 2026
- Product code
- MPB
- Device type
- Catheter, Hemodialysis, Non-Implanted
- Reason
- this is a downstream recall of class I recall RES 98777
- Root cause
- Material/Component Contamination
- Quantity
- 22,980
- Code info
- REF/UDI-DI/Lot(Expiration): 5625150/801741042096/ REKS1082(8/31/2026), REKS2493(10/31/2026), REKU1654(10/31/2026), REKV2899(1/31/2027), REKX0416(3/31/2027), REKY1371(4/30/2027), REKZ0520(5/31/2027); 5625200/801741042102/ REKQ3365(8/31/2026), REKR0913(9/30/2026), REKR3442(9/30/2026), REKS3566(10/31/2026), REKT3039(11/30/2026), REKV0934(12/31/2026), REKW2112(1/31/2027), REKX1756(3/31/2027), REKY1379(4/30/2027), REKZ2330(5/31/2027), RELP1350(7/31/2027); 5625240/801741042119/ REKS1561(9/30/2026), REKU1624(12/31/2026), REKW1234(2/28/2027), REKY0255(4/30/2027), REKY2419(4/30/2027), RELP2149(7/31/2027); 5625300/801741042126/ REKQ1106(8/31/2026), REKS1554(10/31/2026), REKW1239(2/28/2027), REKY1363(4/30/2027), RELN2943(6/30/2027); 5626120/801741042133/ REKU1592(12/31/2026), REKW0662(2/28/2027), REKY2397(4/30/2027); 5626150/801741042140/ REKQ3359(8/31/2026), REKS3561(10/31/2026), REKW0658(2/28/2027), REKY1388(4/30/2027), RELP1359(7/31/2027); 5626200/801741042157/ REKW1244(2/28/2027), REKY0237(4/30/2027); 5626240/801741042164/ REKR2191(9/30/2026), REKU1680(12/31/2026), REKW1230(1/31/2027), REKY0250(4/30/2027); 5575150/ 5766200/801741045714/ REKT1903(11/30/2026)
- Distribution
- US: 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
- Voluntary or mandated
- Voluntary: Firm initiated
- Location
- Salt Lake City, UT, United States