Bard Access Systems, Inc. recalls Power-Trialysis Short-Term Straight Dialysis Catheter
Reason for recall
this is a downstream recall of class I recall RES 98777
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Power-Trialysis Short-Term Straight Dialysis Catheter1 code
- 5605150
Power-Trialysis Short-Term Straight Dialysis Catheter1 code
- 5605200
Power-Trialysis Short-Term Straight Dialysis Catheter1 code
- 5605240
Power-Trialysis Short-Term Straight Dialysis Catheter1 code
- 5605300
Power-Trialysis Short-Term Curved Extension Dialysis Catheter1 code
- 5615120
Power-Trialysis Short-Term Curved Extension Dialysis Catheter1 code
- 5615150
Power-Trialysis Short-Term Curved Extension Dialysis Catheter1 code
- 5615200
Power-Trialysis Short-Term Curved Extension Dialysis Catheter1 code
- 5615240
Power-Trialysis Short-Term Alphacurve Dialysis Catheter1 code
- 5655120
Power-Trialysis Short-Term Alphacurve Dialysis Catheter1 code
- 5655150
Power-Trialysis Short-Term Alphacurve Dialysis Catheter1 code
- 5655200
Power-Trialysis Short-Term Alphacurve Dialysis Catheter1 code
- 5655240
Power-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray1 code
- 5605200G
Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter1 code
- 5855200G
Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter1 code
- 5865150G
Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter1 code
- 5855150
Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter1 code
- 5855200
Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter1 code
- 5855240
Power-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter1 code
- 5855300
Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter1 code
- 5865120
Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter1 code
- 5865150
Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter1 code
- 5865200
Power-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter1 code
- 5865240
Lot / code information
- 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) — +141 moreShow all
(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)
What the firm is doing
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
DistributionShow detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2984-2026
- FDA 510(k) clearance · K133456The device's official FDA premarket clearance record
- FDA 510(k) clearance · K141531The device's official FDA premarket clearance record
- FDA device classification · MPBOfficial FDA classification for this device type
- CFR regulation · 21 CFR 876.5540The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find Bard Access Systems, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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