{ "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": "2026-09-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "197463", "product_res_number": "Z-1051-2023", "event_date_initiated": "2023-01-04", "event_date_posted": "2023-02-01", "recall_status": "Open, Classified", "res_event_number": "91327", "product_code": "LJS", "k_numbers": [ "K830406", "K871998" ], "product_description": "Catalog Number / Product Description\n0601600 2.7F Broviac CV Catheter Repair Kit \n0601610 4.2 Fr Broviac CV Catheter Repair Kit \n0601620 6.6F Broviac CV Catheter Repair Kit \n0601630 9.6F Hickman CV Catheter Repair Kit \n0601680 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)\n0601690 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)\n0601700 9F Hickman CV Catheter Repair Kit \n0601710 12F Hickman CV Catheter Repair Kit \n0601730 Hickman / Leonard CV Catheter Repair Kit (all except 13.5F)\n0601740 12.5F Hickman CV Catheter Repair Kit \n0601750 10F Leonard CV Catheter Repair Kit \n0601760 7F Hickman CV Catheter Repair Kit \n0601790 10F Hickman CV Catheter Repair Kit", "code_info": "Catalog Numbers/Lot-Serial Numbers/UDI Code:\n0601610 /\tREFX4541 / (01)00801741036385(17)230930(10)REFX4541\n0601610 /\tREFX5636 / (01)00801741036385(17)240930(10)REFX5636\n0601610 /\tREFY2820 / (01)00801741036385(17)230930(10)REFY2820\n0601610 /\tREGP0198\t / (01)00801741036385(17)241231(10)REGP0198\n0601610 /\tREGP2720\t / (01)00801741036385(17)250131(10)REGP2720\n0601610 /\tREGQ1144 / (01)00801741036385(17)250228(10)REGQ1144\n0601620 /\tREES0680 / (01)00801741074479(17)230430(10)REES0680\n0601620 /\tREEU0726 / (01)00801741074479(17)230630(10)REEU0726\n0601620 /\tREEU1536 / (01)00801741074479(17)230630(10)REEU1536\n0601620 /\tREEU3300 / (01)00801741074479(17)230630(10)REEU3300\n0601620 /\tREEV1906 / (01)00801741074479(17)230731(10)REEV1906\n0601620 /\tREFX4543 / (01)00801741074479(17)230930(10)REFX4543\n0601630 /\tREEQ0746 / (01)00801741036408(17)230228(10)REEQ0746\n0601630 /\tREGN2382 / (01)00801741036408(17)241231(10)REGN2382\n0601630 /\tREGQ1143 / (01)00801741036408(17)250228(10)REGQ1143\n0601680 /\tREER3749 / (01)00801741036415(17)230331(10)REER3749\n0601680 /\tREEU1626 / (01)00801741036415(17)230630(10)REEU1626\n0601690 /\tREES0716 / (01)00801741036422(17)230131(10)REES0716\n0601690 /\tREFX1172 / (01)00801741036422(17)230131(10)REFX1172\n0601690 /\tREFY0874 / (01)00801741036422(17)230131(10)REFY0874\n0601700 /\tREES2549 / (01)00801741036439(17)230430(10)REES2549\n0601700 /\tREGQ1154 / (01)00801741036439(17)230731(10)REGQ1154\n0601710 /\tREFY2852 / (01)00801741036446(17)231031(10)REFY2852\n0601730 /\tREGQ1174 / (01)00801741036453(17)240229(10)REGQ1174\n0601740 /\tREFZ0223 / (01)00801741036460(17)230930(10)REFZ0223\n0601750 /\tREFY0744 / (01)00801741036477(17)230731(10)REFY0744\n0601760 /\tREEU1534 / (01)00801741036484(17)230630(10)REEU1534\n0601790 /\tREFW1651 / (01)00801741036514(17)231031(10)REFW1651\n7741700 /\tREET0877 / (01)00801741036798(17)240131(10)REET0877\n7741800 /\tREER0703 / (01)00801741036804(17)240531(10)REER0703\n7741800 /\tREFW3156 / (01)00801741036804(17)250131(10)REFW3156\n0601600 /\tREES06790 / (01)00801741036378(17)220831(10)REES0679\n0601600 /\tREES2528 / (01)00801741036378(17)220831(10)REES2528\n0601600 /\tREES3456 / (01)00801741036378(17)220831(10)REES3456\n0601610 /\tREEQ1683 / (01)00801741036385(17)220831(10)REEQ1683\n0601610 /\tREEQ4180 / (01)00801741036385(17)220831(10)REEQ4180\n0601610 /\tREER3748 / (01)00801741036385(17)220831(10)REER3748\n0601610 /\tREES0715 / (01)00801741036385(17)220831(10)REES0715\n0601610 /\tREET3287 / (01)00801741036385(17)220831(10)REET3287\n0601620 /\tREEQ2751 / (01)00801741074479(17)220831(10)REEQ2751\n0601620 /\tREEQ4141 / (01)00801741074479(17)220831(10)REEQ4141\n0601620 /\tREER3694 / (01)00801741074479(17)220831(10)REER3694\n0601620 /\tREET3269 / (01)00801741074479(17)220831(10)REET3269\n0601630 /\tREEU0729 / (01)00801741036408(17)220831(10)REEU0729\n0601630 /\tREEU3297 / (01)00801741036408(17)220831(10)REEU3297\n0601690 /\tREEU0727 / (01)00801741036422(17)220831(10)REEU0727\n0601700 /\tREER3695 / (01)00801741036439(17)220831(10)REER3695\n0601710 /\tREER3750 / (01)00801741036446(17)220831(10)REER3750\n0601710 /\tREEU3314 / (01)00801741036446(17)220831(10)REEU3314\n0601740 /\tREEU3298 / (01)00801741036460(17)220831(10)REEU3298\n0601750 /\tREEU0730 / (01)00801741036477(17)220831(10)REEU0730\n0601750 /\tREEU1608 / (01)00801741036477(17)220831(10)REEU1608\n0601760 /\tREER3696 / (01)00801741036484(17)220831(10)REER3696\n0601760 /\tREES3457 / (01)00801741036484(17)220831(10)REES3457\n0601760 /\tREET2794 / (01)00801741036484(17)220831(10)REET2794\n0601760 /\tREEU1184 / (01)00801741036484(17)220831(10)REEU1184", "firm_fei_number": "2020394", "recalling_firm": "Bard Peripheral Vascular Inc", "address_1": "1625 W 3rd St Bldg 1 1625 W 3rd St", "address_2": "Bldg 1", "city": "Tempe", "state": "AZ", "postal_code": "85281-2438", "additional_info_contact": "Padraic OBrien\n480-597-8203", "reason_for_recall": "Due to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable).", "root_cause_description": "Under Investigation by firm", "action": "On 01/04/2023, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via FedEx or email to customers informing them that the firm has received complaints regarding hardened/coagulated adhesive associated with various Catheter Repair Kits. as a result of the hardened/coagulated adhesive, there is the potential to cause delays whilst an alternative repair kit, adhesive or replacement catheter is obtained, therefore potentially prolonging surgery or necessitating exchange.\n\nCustomer are instructed to:\n1.\tDiscontinue use of product listed in Attachment A, and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process.\n2.\tShare this notification with all users within their facility network of the product to ensure they are also aware of this field action.\n3.\tIf customers purchased this product from a distributor, contact the distributor for further instructions and credit resolution.\n4.\tComplete and return the attached Customer Response Form and return it to the BD contact noted on the form whether or not they have any of the product so that BD may acknowledge their receipt of this notification and subsequently process any applicable credit regarding impacted product. \n5.\tIndicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of.\n\nFor Distributors (in addition to the above):\nIdentify all customers within their distribution network that purchased any affected product and provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf.\n\nContact their BD representative if they require assistance with this process or they may also contact the number below for further assistance.\n\nNorth American Regional Complaint Center\tPhone: 1-844-8BD- LIFE (1-844-823-5433)\nSay Recall when prompted M-F 8am - 5pm CT\nEmail: productcomplaints@bd.com", "product_quantity": "7520 (Breakdown: US 3764; OUS 3243)", "distribution_pattern": "Worldwide Distribution: U.S.(nationwide): AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV; OUS (foreign) countries of: Australia, Belgium, Canada, Hong Kong and Japan.\n\nO.U.S.: Australia, Belgium, Canada, Hong Kong, and Japan.", "openfda": { "k_number": [ 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"K080604", "K082481", "K142267", "K130876", "K964929", "K132567", "K072518", "K071875", "K903648", "K040446", "K070002", "K071361", "K152819", "K833442", "K100635", "K091261", "K180546", "K241910", "K840742", "K834473", "K061986", "K111244", "K964447", "K042126", "K882448", "K092347", "K050931", "K954302", "K051690", "K896598", "K993442", "K963215", "K232594", "K070615", "K161496", "K110914", "K081904", "K053501", "K935145", "K962849", "K980090", "K122423", "K871998", "K840958", "K041849", "K121089", "K243941", "K840846", "K141634", "K844080", "K954422", "K083873", "K173956", "K946250", "K924677", "K061179", "K083763", "K970269", "K831802", "K142616", "K933884", "K172397", "K831845", "K961856", "K951098", "K924851", "K932433", "K091324", "K222232", "K843450", "K062425", "K930630", "K830233", "K945956", "K021704", "K953436", "K140266", "K121941", "K030270", "K051672", "K893126", "K972555", "K992424", "K053345", "K042461", "K932198", "K111906", "K091586", "K041088", "K063240", "K141633", 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"2011171", "3011237770", "3030714660", "3006942602", "3005704822", "3015537049", "1722746", "1018233", "1721686", "1223004", "3013788631", "3013041594", "3004134316", "3015060216", "2527072", "1721504", "2246552", "3011137372", "1000314502", "1061124", "3005636544", "3013162291", "3006950086", "3009211636", "9681477", "3030148766", "1423537", "3007697249", "3007544874", "3010882065", "3018094310", "3008236846", "3007137787", "3010882708", "3013233645", "3013750125", "1644312" ], "fei_number": [ "1000512168", "3006082230", "3011534620", "3007207906", "3035111606", "3013666218", "3021570645", "1718873", "3015225571", "3010532612", "3016727301", "1000117748", "3009888344", "3005747797", "3006097687", "1721676", "1220477", "3024673", "3006425876", "3004111573", "3015309643", "3038181770", "3003737899", "3012536737", "3004753388", "1625425", "3015859709", "2183744", "1820334", "3006260740", "3002808464", "1921846", "2245270", "1048735", "3013501772", "1319211", "3016472589", "3010041511", "3013557562", "3002558692", "1000484830", "3003898360", "3010827261", "1000306216", "1219930", "3003915875", "2518902", "3033589330", "3001236905", "3000209794", "2011171", "1000138054", "3011237770", "3030714660", "3006942602", "3005704822", "3000206435", "3015537049", "1018233", "3003473227", "1721686", "3013788631", "3013041594", "3003094851", "3002807439", "3004134316", "3015060216", "2527072", "1721504", "3001237338", "2246552", "1000314502", "3005636544", "3013162291", "3006950086", "3009211636", "3030148766", "1000115408", "3007697249", "3007544874", "1000306139", "3018094310", "3008236846", "3007137787", "3010882708", "3013233645", "1000120555", "3013750125", "3002468371" ], "device_name": "Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days", "medical_specialty_description": "General Hospital", "regulation_number": "880.5970", "device_class": "2" } } ] }