Z-2985-2026Class I

DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter...

Name: Z-2985-2026 DuoGlide Short-Term Straight Dialysis Catheter, REF: 5625150; DuoGlide Short-Term Straight Dialysis Catheter...
Creator: Bard Access Systems, Inc.
Published: 2026-08-10
License: https://open.fda.gov/license/

Bard Access Systems, Inc. / initiated 2026-08-10 / Open, Classified

FDA source

Recall record

Recall number: Z-2985-2026
Classification: Class I
Status: Open, Classified
Initiated: 2026-08-10
Posted: 2026-09-11
Recalling firm: Bard Access Systems, Inc.
Product: 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
Product code: MPB Catheter, Hemodialysis, Non-Implanted
Reason for recall: this is a downstream recall of class I recall RES 98777
FDA root cause: Material/Component Contamination
Action: On 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) If affected Sodium chloride ampule was previously used without issue, no additional treatment or clinical follow up is required. 5) If affected Sodium chloride ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions. Take the Following Actions: a) Circulate this notice to all those who need to be aware within your organization or to any organization where the potentially affected products have been transferred. b) Post this notice on all inventory storage locations and any location where the product may be used. c) Label all affected trays using the template provided to facilitate easy identification of products containing the affected ampules. The label can be printed using Avery template 5160. d) Apply the labels to the product without covering or obscuring any regulatory or traceability information. e) Apply to the top web of the tray by pressing firmly to ensure adhesion, but don't damage or compromise the sterile barrier. Distributors are asked to identify all customers within their distribution network that purchased any affected product and to provide a copy of the customer letter to all customers. Complete and return response form via email to [email protected] Report complaints to firm via: Phone: 1-844-823-5433 or Email: [email protected]
Quantity in commerce: 22,980
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
Product codes and lots: 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)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2985-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2984-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11
Z-2985-2026	Class I	Ongoing	Voluntary: Firm initiated	2026-09-23	2026-09-11

Product code MPB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-18. View this recall on fda.gov (opens on fda.gov)