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U.S. Department of Health and Human Services

Class 1 Device Recall BD Acute Dialysis trays

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 Class 1 Device Recall BD Acute Dialysis trayssee related information
Date Initiated by FirmAugust 10, 2026
Date PostedSeptember 11, 2026
Recall Status1 Open3, Classified
Recall NumberZ-2985-2026
Recall Event ID 99534
510(K)NumberK030268 K090102 
Product Classification Catheter, hemodialysis, non-implanted - Product Code MPB
ProductDuoGlide 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
Code Information 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)
FEI Number 3006260740
Recalling Firm/
Manufacturer		 Bard Access Systems, Inc.
605 N 5600 W
Salt Lake City UT 84116-3738
For Additional Information Contact
801-522-5000
Manufacturer Reason
for Recall		this is a downstream recall of class I recall RES 98777
FDA Determined
Cause 2		Material/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) 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 BDRC8@bd.com Report complaints to firm via: Phone: 1-844-823-5433 or Email: productcomplaints@bd.com
Quantity in Commerce22,980
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
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MPB
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