{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "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", "k_numbers": [ "K133456", "K141531" ], "product_description": "Power-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605150; \r\nPower-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605200; \r\nPower-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605240;\r\nPower-Trialysis Short-Term Straight Dialysis Catheter, REF: 5605300;\r\nPower-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615120;\r\nPower-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615150;\r\nPower-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615200; \r\nPower-Trialysis Short-Term Curved Extension Dialysis Catheter, REF: 5615240;\r\nPower-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655120; \r\nPower-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655150; \r\nPower-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655200;\r\nPower-Trialysis Short-Term Alphacurve Dialysis Catheter, REF: 5655240; \r\nPower-Trialysis Short-Term Straight Dialysis Catheter Full Procedure Tray, REF: 5605200G; \r\nPower-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200G; \r\nPower-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150G;\r\n\r\nPower-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855150;\r\nPower-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855200;\r\nPower-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855240;\r\nPower-Trialysis Slim-Cath Straight Short-Term Dialysis Catheter, REF: 5855300;\r\nPower-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865120;\r\nPower-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865150;\r\nPower-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865200;\r\nPower-Trialysis Slim-Cath Precurved Extension Short-Term Dialysis Catheter, REF: 5865240", "code_info": "REF/UDI-DI/Lot(Expiration):\n5605150/801741086953/\nREKQ2236(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);\n\n5605200/801741086960/\nREKQ3355(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);\n\n5605240/801741086977/\nREKQ3367(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);\n\n\n5605300/801741086984/\nREKR3428(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);\n\n5615120/801741075087/\nREKR0770(9/30/2026), REKR2157(9/30/2026), REKT2999(11/30/2026), REKX1764(1/31/2027), REKZ0393(2/28/2027);\n\n5615150/801741075094/\nREKQ3350(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);\n\n5615200/801741075100/\nREKQ1130(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);\n\n5615240/801741075117/\nREKQ3364(8/31/2026), REKR3434(9/30/2026), REKU2632(12/31/2026), REKX0415(12/31/2026), REKY0249(3/31/2027), RELN2947(6/30/2027);\n\n5655120/801741066054/\nREKV0931(1/31/2027), REKX0578(3/31/2027), REKY2420(2/28/2027);\n\n5655150/00801741066061/\nREKR2161(9/30/2026), REKV0928(10/31/2026), REKX3746(3/31/2027), REKY2398(3/31/2027), RELP1351(7/31/2027);\n\n5655200/801741066078/\nREKQ3353(8/31/2026), REKR2150(9/30/2026), REKV1673(10/31/2026), REKW2116(1/31/2027), RELN0858(6/30/2027);\n\n5655240/801741066085/\nREKS2492(10/31/2026), REKX1759(2/28/2027), REKY0238(4/30/2027);\n\n5605200G/801741100154/\nREKQ2567(8/31/2026), REKV1675(1/31/2027), REKX2411(3/31/2027), REKZ2321(5/31/2027);\n\n5855200G/801741107146/\nREKS2190(10/31/2026), REKX2413(2/28/2027), REKY0258(4/30/2027), REKZ0385(5/31/2027);\n\n5865150G/00801741107153/\nREKQ2583(8/31/2026), REKY1373(4/30/2027)\n\n5855150/801741107412/\nREKR0766(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);\n\n5855200/801741107160/\nREKQ3347(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);\n\n5855240/801741107177/\nREKQ2576(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);\n\n5855300/801741107184/\nREKQ1117(8/31/2026), REKR2204(9/30/2026), REKU1254(12/31/2026), REKY1364(4/30/2027);\n\n5865120/801741107191/\nREKS3553(10/31/2026), REKU1626(12/31/2026), REKY0241(4/30/2027), RELN0881(6/30/2027);\n\n5865150/801741107207/\nREKQ1100(8/31/2026), REKS1552(10/31/2026), REKU1594(10/31/2026), REKV2895(1/31/2027), REKX3723(3/31/2027), REKZ0397(5/31/2027);\n\n5865200/801741107214/\nREKS1549(10/31/2026), REKV0941(12/31/2026), REKY1381(4/30/2027), RELN0861(6/30/2027);\n\n5865240/801741107221/\nREKS2488(10/31/2026), REKU1253(12/31/2026), REKW2113(1/31/2027), REKY1365(4/30/2027);", "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", "action": "On 8/10/2026, recall notices were mailed or emailed to customers and distributors who were asked to do the following:\n\n1) 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.\n\n2) Secure an alternative local Sodium chloride prior to entering the procedural environment.\n\n3) 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. \n\n4) If affected Sodium chloride ampule was previously used without issue, no additional treatment or clinical follow up is required.\n\n5) If affected Sodium chloride ampule was previously used with issue, report the incident per institutional guidelines and take any necessary actions.\n\nTake the Following Actions:\n\na) 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.\n\nb) Post this notice on all inventory storage locations and any location where the product may be used.\n\nc) 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.\n\nd) Apply the labels to the product without covering or obscuring any regulatory or traceability information.\n\ne) Apply to the top web of the tray by pressing firmly to ensure adhesion, but don't damage or compromise the sterile barrier.\n\nDistributors 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.\n\nComplete and return response form via email to BDRC8@bd.com\n\nReport complaints to firm via: Phone: 1-844-823-5433 or Email: productcomplaints@bd.com", "product_quantity": "149521", "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", "openfda": { "k_number": [ "K030209", "K963446", "K991431", "K040301", "K063355", "K993933", "K974236", "K022221", "K980438", "K192302", "K192807", "K952660", "K120674", "K923691", "K090102", "K001958", "K110793", "K893188", "K071145", "K871360", "K250836", "K070234", "K122091", "K955002", "K153190", "K896252", "K200426", "K100451", "K991320", "K163458", "K102833", "K965178", "K161504", "K983511", "K010778", "K984022", "K880583", "K030268" ], "registration_number": [ "9610849", "3006621386", "1721676", "3015859709", "1056186", "1000563940", "1061124", "1722746", "2518902", "3007836437", "3000247873", "2030624", "3007137787", "3009888344", "3010882065", "1319639", "3009211636", "3004784537", "3006260740", "3006082230", "3003661577", "3030574705", "2527072", "3010131137", "1820334", "8041145", "3011137372", "3010041511", "9617592", "9680794", "3004134316", "3012050423", "1282497", "1018233", "2011171", "3014656749", "3007544634", "3035111606", "3003915875", "3006425876" ], "fei_number": [ "3006621386", "1721676", "3015859709", "1000563940", "1000138054", "3006097687", "2518902", "3007836437", "3000247873", "3007137787", "3009888344", "3003737899", "3002807391", "3009211636", "3004784537", "3006260740", "1000306216", "3006082230", "3005747797", "3003661577", "3030574705", "2527072", "3010131137", "1820334", "3010041511", "3004134316", "3012050423", "1000132332", "1282497", "1018233", "3002468371", "3002974635", "2011171", "3014656749", "3000206435", "3007544634", "3035111606", "3003915875", "3006425876", "1000512168" ], "device_name": "Catheter, Hemodialysis, Non-Implanted", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.5540", "device_class": "2" } } ] }