Device recalls

Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; P…

Bard Access Systems, Inc. · this is a downstream recall of class I recall RES 98777

Open, ClassifiedMaterial/Component ContaminationZ-2984-2026
Open FDA's page for this record
Cfres ID
221786
Product res number
Z-2984-2026
Event date initiated
2026-08-10
Event date posted
2026-09-11
Recall status
Open, Classified
Res event number
99534
Product code
MPB
Firm FEI number
3006260740
Recalling firm
Bard Access Systems, Inc.
Address 1
605 N 5600 W
City
Salt Lake City
State
UT
Postal code
84116-3738
Additional info contact
801-522-5000
Reason for recall
this is a downstream recall of class I recall RES 98777
Root cause description
Material/Component Contamination
Product quantity
149521
Product description

Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240; Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615120; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615150; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615200; Power-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615240; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655120; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655150; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655200; Power-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655240; Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray, REF: 5605200G; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200G; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150G; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855150; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855240; Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855300; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865120; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865200; Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865240

Code info

REF/UDI-DI/Lot(Expiration): 5605150/801741086953/ REKQ2236(08/31/2026), REKR0948(08/31/2026), REKR3422(09/30/2026), REKR3433(09/30/2026), REKS1563(10/31/2026), REKS3564(09/30/2026), REKS3559(10/31/2026), REKT0573(11/30/2026), REKT1722(09/30/2026), REKT3057(10/31/2026), REKU1678(12/31/2026), REKV0926(01/31/2027), REKW0664(02/28/2027), REKX0410(03/31/2027), REKX1755(03/31/2027), REKY2464(03/31/2027), REKZ2323(05/31/2027), RELN2937(06/30/2027); 5605200/801741086960/ REKQ3355(8/31/2026, REKQ3362(8/31/2026), REKR0756(9/30/2026), REKR2159(9/30/2026), REKR2214(9/30/2026), REKS1550(10/31/2026), REKS1559(10/31/2026), REKS2495(10/31/2026), REKT0576(10/31/2026), REKT0579(11/30/2026), REKT2201(11/30/2026), REKT3018(11/30/2026), REKU2636(12/31/2026), REKU3679(12/31/2026), REKV2415(12/31/2026), REKW2742(2/28/2027), REKX0576(3/31/2027), REKX2423(3/31/2027), REKZ0519(5/31/2027), RELN1850(6/30/2027); 5605240/801741086977/ REKQ3367(8/31/2026), REKR0762(8/31/2026), REKS3554(8/31/2026), REKT2178(11/30/2026), REKU3687(12/31/2026), REKW0663(2/28/2027), REKW2120(2/28/2027), REKX0561(12/31/2026), REKY1369(3/31/2027), REKZ0376(5/31/2027), RELN1835(6/30/2027); 5605300/801741086984/ REKR3428(9/30/2026), REKS2486(10/31/2026), REKT3038(11/30/2026), REKV1678(10/31/2026), REKW2736(1/31/2027), REKX3721(3/31/2027), REKY2472(4/30/2027); 5615120/801741075087/ REKR0770(9/30/2026), REKR2157(9/30/2026), REKT2999(11/30/2026), REKX1764(1/31/2027), REKZ0393(2/28/2027); 5615150/801741075094/ REKQ3350(8/31/2026), REKR2193(9/30/2026), REKS1070(10/31/2026), REKS2494(10/31/2026), REKT0570(11/30/2026), REKT2132(10/31/2026), REKU1247(10/31/2026), REKU3675(12/31/2026), REKV1674(12/31/2026), REKW1228(2/28/2027), REKW2108(1/31/2027), REKX2412(3/31/2027), REKY0262(3/31/2027), REKZ0396(5/31/2027), RELN0870(6/30/2027), RELP0317(7/31/2027); 5615200/801741075100/ REKQ1130(8/31/2026), REKQ3357(8/31/2026), REKR0905(9/30/2026), REKR2215(9/30/2026), REKS1083(10/31/2026), REKT1724(11/30/2026), REKU1255(12/31/2026), REKU3680(12/31/2026), REKV2897(1/31/2027), REKW2743(2/28/2027), REKX0413(12/31/2026), REKX3745(1/31/2027), REKY2418(4/30/2027), REKZ0377(5/31/2027), RELP0308(7/31/2027); 5615240/801741075117/ REKQ3364(8/31/2026), REKR3434(9/30/2026), REKU2632(12/31/2026), REKX0415(12/31/2026), REKY0249(3/31/2027), RELN2947(6/30/2027); 5655120/801741066054/ REKV0931(1/31/2027), REKX0578(3/31/2027), REKY2420(2/28/2027); 5655150/00801741066061/ REKR2161(9/30/2026), REKV0928(10/31/2026), REKX3746(3/31/2027), REKY2398(3/31/2027), RELP1351(7/31/2027); 5655200/801741066078/ REKQ3353(8/31/2026), REKR2150(9/30/2026), REKV1673(10/31/2026), REKW2116(1/31/2027), RELN0858(6/30/2027); 5655240/801741066085/ REKS2492(10/31/2026), REKX1759(2/28/2027), REKY0238(4/30/2027); 5605200G/801741100154/ REKQ2567(8/31/2026), REKV1675(1/31/2027), REKX2411(3/31/2027), REKZ2321(5/31/2027); 5855200G/801741107146/ REKS2190(10/31/2026), REKX2413(2/28/2027), REKY0258(4/30/2027), REKZ0385(5/31/2027); 5865150G/00801741107153/ REKQ2583(8/31/2026), REKY1373(4/30/2027) 5855150/801741107412/ REKR0766(9/30/2026), REKR2162(8/31/2026), REKS2499(10/31/2026), REKU2621(12/31/2026), REKW2723(1/31/2027), REKY0252(4/30/2027), REKY2469(4/30/2027), RELN2934(6/30/2027); 5855200/801741107160/ REKQ3347(8/31/2026), REKR2211(9/30/2026), REKS3567(8/31/2026), REKU2629(12/31/2026), REKW0656(1/31/2027), REKX0406(3/31/2027), REKY0246(4/30/2027), RELP0770(7/31/2027); 5855240/801741107177/ REKQ2576(8/31/2026), REKR3432(9/30/2026), REKU3683(10/31/2026) , REKW0667(2/28/2027), REKY0240(4/30/2027), REKY2412(3/31/2027), RELN0859(6/30/2027); 5855300/801741107184/ REKQ1117(8/31/2026), REKR2204(9/30/2026), REKU1254(12/31/2026), REKY1364(4/30/2027); 5865120/801741107191/ REKS3553(10/31/2026), REKU1626(12/31/2026), REKY0241(4/30/2027), RELN0881(6/30/2027); 5865150/801741107207/ REKQ1100(8/31/2026), REKS1552(10/31/2026), REKU1594(10/31/2026), REKV2895(1/31/2027), REKX3723(3/31/2027), REKZ0397(5/31/2027); 5865200/801741107214/ REKS1549(10/31/2026), REKV0941(12/31/2026), REKY1381(4/30/2027), RELN0861(6/30/2027); 5865240/801741107221/ REKS2488(10/31/2026), REKU1253(12/31/2026), REKW2113(1/31/2027), REKY1365(4/30/2027);

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 BDRC8@bd.com Report complaints to firm via: Phone: 1-844-823-5433 or Email: productcomplaints@bd.com

Distribution pattern

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

K numbers
K133456, K141531
Harmonized identifiers (openFDA)
Device name
Catheter, Hemodialysis, Non-Implanted
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5540
Device class
2
K number
K163458, K893188, K984022, K192807, K030268, K070234, K965178, K063355, K010778, K952660, K871360, K896252, K980438, K974236, K963446, K030209, K120674, K161504, K122091, K200426, K880583, K071145, K250836, K991431, K923691, K102833, K090102, K022221, K001958, K983511, K991320, K993933, K110793, K192302, K040301, K100451, K955002, K153190
Registration number
3009211636, 3011137372, 3012050423, 1282497, 1056186, 3035111606, 8041145, 1721676, 3010131137, 3004519921, 2030624, 9610849, 1820334, 3006621386, 3009888344, 2011171, 3007836437, 2518902, 3006425876, 9617592, 1018233, 3014656749, 2527072, 3007544634, 1000563940, 9680794, 3006082230, 3010882065, 3003661577, 3000247873, 3007137787, 1722746, 3004784537, 3030574705, 3010041511, 3004134316, 1319639, 3015859709, 3003915875, 3006260740 +1 more
FEI number
1000306216, 3005747797, 3009211636, 3012050423, 3005846326, 3002468371, 1282497, 3006097687, 3035111606, 1721676, 3010131137, 1820334, 3006621386, 3009888344, 2011171, 3000206435, 3007836437, 2518902, 3002807391, 3006425876, 1018233, 1000132332, 3014656749, 2527072, 3003737899, 3007544634, 1000563940, 3006082230, 3003661577, 3000247873, 1000512168, 1000138054, 3007137787, 3004784537, 3030574705, 3010041511, 3004134316, 3015859709, 3003915875, 3006260740 +1 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.