Device recall

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

FDA recall source

Recall number

Z-2984-2026

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

149521

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);

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

Related 510(k)s

K133456K141531

Location

Salt Lake City, UT, United States