{
  "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": "2026-09-10",
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  "results": [
    {
      "cfres_id": "217917",
      "product_res_number": "Z-1367-2026",
      "event_date_initiated": "2025-12-12",
      "event_date_posted": "2026-02-13",
      "recall_status": "Open, Classified",
      "res_event_number": "98222",
      "product_code": "LJS",
      "k_numbers": [
        "K830233",
        "K830256"
      ],
      "product_description": "Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060",
      "code_info": "Product Name: Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600060\nUDI code: (01)00801741051692(17)300728(10)HUKV0547\nLot Number: HUKV0547\n\nProduct Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600100\nUDI code:\n(01)00801741051708(17)300628(10)HUKU0307\n(01)00801741051708(17)300828(10)HUKW1312\nLot Number:\nHUKU0307\nHUKW1312\n\nProduct Name: Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray (Short External Length) with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600120\nUDI code: (01)00801741051715(17)300628(10)HUKU0274\nLot Number: HUKU0274\n\nProduct Name: Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600310\nUDI code:\n(01)00801741051739(17)300428(10)HUKS0783\n(01)00801741051739(17)300628(10)HUKU0250\n(01)00801741051739(17)300628(10)HUKU0310\nLot Number:\nHUKS0783\nHUKU0250\nHUKU0310\n\nProduct Name: Hickman 12 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600350\nUDI code:\n(01)00801741051777(17)300428(10)HUKR1359\n(01)00801741051777(17)300428(10)HUKS0811\n(01)00801741051777(17)300628(10)HUKU0316\nLot Number:\nHUKR1359\nHUKS0811\nHUKU0316\n\nProduct Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600520\nUDI code:\n(01)00801741051807(17)270528(10)HUKS1468\n(01)00801741051807(17)270528(10)HUKU0246\n(01)00801741051807(17)270528(10)HUKU0278\n(01)00801741051807(17)270528(10)HUKU0289\n(01)00801741051807(17)270528(10)HUKU0305\n(01)00801741051807(17)270528(10)HUKU0327\n(01)00801741051807(17)270528(10)HUKU0338\n(01)00801741051807(17)270528(10)HUKU0353\n(01)00801741051807(17)270528(10)HUKW0164\n(01)00801741051807(17)280328(10)HUKW1278\n(01)00801741051807(17)280328(10)HUKW1285\nLot Number:\nHUKS1468\nHUKU0246\nHUKU0278\nHUKU0289\nHUKU0305\nHUKU0327\nHUKU0338\nHUKU0353\nHUKW0164\nHUKW1278\nHUKW1285\n\nProduct Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600540\nUDI code:\n(01)00801741051821(17)290428(10)HUKR0064\n(01)00801741051821(17)290628(10)HUKR0065\n(01)00801741051821(17)290628(10)HUKR0067\n(01)00801741051821(17)300128(10)HUKU0252\n(01)00801741051821(17)300128(10)HUKU0270\n(01)00801741051821(17)300128(10)HUKU0279\n(01)00801741051821(17)300128(10)HUKU0308\n(01)00801741051821(17)300128(10)HUKU0334\n(01)00801741051821(17)300328(10)HUKV0359\n(01)00801741051821(17)300328(10)HUKV0550\n(01)00801741051821(17)300328(10)HUKV0560\n(01)00801741051821(17)300328(10)HUKW0156\n(01)00801741051821(17)300328(10)HUKW0159\nLot Number:\nHUKR0064\nHUKR0065\nHUKR0067\nHUKU0252\nHUKU0270\nHUKU0279\nHUKU0308\nHUKU0334\nHUKV0359\nHUKV0550\nHUKV0560\nHUKW0156\nHUKW0159\n\nProduct Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600560\nUDI code:\n(01)00801741051845(17)290828(10)HUKS0776\n(01)00801741051845(17)290828(10)HUKS0816\n(01)00801741051845(17)290928(10)HUKS1220\n(01)00801741051845(17)290928(10)HUKU0302\n(01)00801741051845(17)290928(10)HUKU0311\n(01)00801741051845(17)300128(10)HUKU0345\n(01)00801741051845(17)300128(10)HUKU0350\n(01)00801741051845(17)300128(10)HUKV0376\n(01)00801741051845(17)300128(10)HUKV0555\nLot Number:\nHUKS0776\nHUKS0816\nHUKS1220\nHUKU0302\nHUKU0311\nHUKU0345\nHUKU0350\nHUKV0376\nHUKV0555\n\nProduct Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600570\nUDI code:\n(01)00801741051869(17)290628(10)HUKR1342\n(01)00801741051869(17)290628(10)HUKR1344\n(01)00801741051869(17)300128(10)HUKR1346\n(01)00801741051869(17)290628(10)HUKR1347\n(01)00801741051869(17)300128(10)HUKR1348\n(01)00801741051869(17)300128(10)HUKR1356\n(01)00801741051869(17)290628(10)HUKR1363\n(01)00801741051869(17)290628(10)HUKR1367\n(01)00801741051869(17)300128(10)HUKR1368\n(01)00801741051869(17)300128(10)HUKS0774\n(01)00801741051869(17)300128(10)HUKU0238\n(01)00801741051869(17)300128(10)HUKU0242\n(01)00801741051869(17)300128(10)HUKU0247\n(01)00801741051869(17)300128(10)HUKU0253\n(01)00801741051869(17)300128(10)HUKU0254\n(01)00801741051869(17)300128(10)HUKU0266\n(01)00801741051869(17)300128(10)HUKU0280\n(01)00801741051869(17)300128(10)HUKU0283\n(01)00801741051869(17)300128(10)HUKU0284\n(01)00801741051869(17)300128(10)HUKU0290\n(01)00801741051869(17)300128(10)HUKU0293\n(01)00801741051869(17)300128(10)HUKU0294\n(01)00801741051869(17)300128(10)HUKU0298\n(01)00801741051869(17)300128(10)HUKU0312\n(01)00801741051869(17)300128(10)HUKU0339\n(01)00801741051869(17)300328(10)HUKU0340\n(01)00801741051869(17)300128(10)HUKU0344\n(01)00801741051869(17)300128(10)HUKU0354\n(01)00801741051869(17)300328(10)HUKV0549\n(01)00801741051869(17)300328(10)HUKV0569\n(01)00801741051869(17)300328(10)HUKV0576\n(01)00801741051869(17)300328(10)HUKV0581\n(01)00801741051869(17)300328(10)HUKW0148\nLot Number:\nHUKR1342\nHUKR1344\nHUKR1346\nHUKR1347\nHUKR1348\nHUKR1356\nHUKR1363\nHUKR1367\nHUKR1368\nHUKS0774\nHUKU0238\nHUKU0242\nHUKU0247\nHUKU0253\nHUKU0254\nHUKU0266\nHUKU0280\nHUKU0283\nHUKU0284\nHUKU0290\nHUKU0293\nHUKU0294\nHUKU0298\nHUKU0312\nHUKU0339\nHUKU0340\nHUKU0344\nHUKU0354\nHUKV0549\nHUKV0569\nHUKV0576\nHUKV0581\nHUKW0148\n\nProduct Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600620\nUDI code:\n(01)00801741051913(17)291028(10)HUJY0302\n(01)00801741051913(17)291028(10)HUJY1095\n(01)00801741051913(17)291128(10)HUJZ1332\n(01)00801741051913(17)291128(10)HUJZ1336\n(01)00801741051913(17)291128(10)HUJZ1339\n(01)00801741051913(17)291128(10)HUJZ1340\n(01)00801741051913(17)300328(10)HUKR1349\n(01)00801741051913(17)300328(10)HUKR1364\n(01)00801741051913(17)300428(10)HUKS0784\n(01)00801741051913(17)300428(10)HUKS0806\n(01)00801741051913(17)300428(10)HUKS1217\n(01)00801741051913(17)230428(10)HUKS1218\n(01)00801741051913(17)300628(10)HUKU0259\n(01)00801741051913(17)300628(10)HUKU0351\n(01)00801741051913(17)300728(10)HUKV0349\n(01)00801741051913(17)300728(10)HUKV0567\n(01)00801741051913(17)300828(10)HUKW0534\nLot Number:\nHUJY0302\nHUJY1095\nHUJZ1332\nHUJZ1336\nHUJZ1339\nHUJZ1340\nHUKR1349\nHUKR1364\nHUKS0784\nHUKS0806\nHUKS1217\nHUKS1218\nHUKU0259\nHUKU0351\nHUKV0349\nHUKV0567\nHUKW0534\n\nProduct Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 600650\nUDI code:\n(01)00801741051975(17)300228(10)HUKQ0535\n(01)00801741051975(17)300428(10)HUKS1474\n(01)00801741051975(17)300428(10)HUKS1483\n(01)00801741051975(17)300628(10)HUKU0313\n(01)00801741051975(17)300628(10)HUKU0317\n(01)00801741051975(17)300628(10)HUKU0328\n(01)00801741051975(17)300728(10)HUKV0354\n(01)00801741051975(17)300728(10)HUKV0371\n(01)00801741051975(17)300828(10)HUKW0171\n(01)00801741051975(17)300828(10)HUKW1283\nLot Number:\nHUKQ0535\nHUKS1474\nHUKS1483\nHUKU0313\nHUKU0317\nHUKU0328\nHUKV0354\nHUKV0371\nHUKW0171\nHUKW1283\n\nProduct Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 606560\nUDI code:\n(01)00801741052019(17)290828(10)HUKR1370\n(01)00801741052019(17)290928(10)HUKS1219\n(01)00801741052019(17)300128(10)HUKU0255\n(01)00801741052019(17)290928(10)HUKU0324\n(01)00801741052019(17)300128(10)HUKV0578\n(01)00801741052019(17)300128(10)HUKW0172\n(01)00801741052019(17)300128(10)HUKW1315\nLot Number:\nHUKR1370\nHUKS1219\nHUKU0255\nHUKU0324\nHUKV0578\nHUKW0172\nHUKW1315\n\nProduct Name:Broviac 6.6 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600100CE\nUDI code:\n(01)00801741051708(17)300628(10)HUKU0307\n(01)00801741051708(17)300828(10)HUKW1312\nLot Number:\nHUKU0307\nHUKW1312\n\nProduct Name:Hickman 7 Fr Dual-Lumen CV Catheter, Cutdown Tray with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600310CE\nUDI code:\n(01)00801741051739(17)300428(10)HUKS0783\n(01)00801741051739(17)300628(10)HUKU0250\n(01)00801741051739(17)300628(10)HUKU0310\nLot Number:\nHUKS0783\nHUKU0250\nHUKU0310\n\nProduct Name:Broviac 4.2 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600520CE\nUDI code:\n(01)00801741051807(17)270528(10)HUKS1468\n(01)00801741051807(17)270528(10)HUKU0246\n(01)00801741051807(17)270528(10)HUKU0278\n(01)00801741051807(17)270528(10)HUKU0289\n(01)00801741051807(17)270528(10)HUKU0305\n(01)00801741051807(17)270528(10)HUKU0338\n(01)00801741051807(17)270528(10)HUKU0353\n(01)00801741051807(17)270528(10)HUKW0164\n(01)00801741051807(17)280328(10)HUKW1278\n(01)00801741051807(17)280328(10)HUKW1285\nLot Number:\nHUKS1468\nHUKU0246\nHUKU0278\nHUKU0289\nHUKU0305\nHUKU0338\nHUKU0353\nHUKW0164\nHUKW1278\nHUKW1285\n\nProduct Name:Broviac 6.6 Fr Single-Lumen CV Catheter Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600540CE\nUDI code:\n(01)00801741051821(17)290428(10)HUKR0064\n(01)00801741051821(17)290628(10)HUKR0065\n(01)00801741051821(17)290628(10)HUKR0067\n(01)00801741051821(17)300128(10)HUKU0252\n(01)00801741051821(17)300128(10)HUKU0270\n(01)00801741051821(17)300128(10)HUKU0279\n(01)00801741051821(17)300128(10)HUKU0308\n(01)00801741051821(17)300128(10)HUKU0334\n(01)00801741051821(17)300328(10)HUKV0359\n(01)00801741051821(17)300328(10)HUKV0550\n(01)00801741051821(17)300328(10)HUKW0156\n(01)00801741051821(17)300328(10)HUKW0159\nLot Number:\nHUKR0064\nHUKR0065\nHUKR0067\nHUKU0252\nHUKU0270\nHUKU0279\nHUKU0308\nHUKU0334\nHUKV0359\nHUKV0550\nHUKW0156\nHUKW0159\n\nProduct Name:Hickman 9.6 Fr Single-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600560CE\nUDI code:\n(01)00801741051845(17)290828(10)HUKS0776\n(01)00801741051845(17)290828(10)HUKS0816\n(01)00801741051845(17)290928(10)HUKS1220\n(01)00801741051845(17)290928(10)HUKU0302\n(01)00801741051845(17)290928(10)HUKU0311\n(01)00801741051845(17)300128(10)HUKU0345\n(01)00801741051845(17)300128(10)HUKU0350\n(01)00801741051845(17)300128(10)HUKV0555\nLot Number:\nHUKS0776\nHUKS0816\nHUKS1220\nHUKU0302\nHUKU0311\nHUKU0345\nHUKU0350\nHUKV0555\n\nProduct Name:Hickman 7 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600570CE\nUDI code:\n(01)00801741051869(17)290628(10)HUKR1342\n(01)00801741051869(17)290628(10)HUKR1344\n(01)00801741051869(17)300128(10)HUKR1346\n(01)00801741051869(17)290628(10)HUKR1347\n(01)00801741051869(17)300128(10)HUKR1348\n(01)00801741051869(17)300128(10)HUKR1356\n(01)00801741051869(17)290628(10)HUKR1363\n(01)00801741051869(17)290628(10)HUKR1367\n(01)00801741051869(17)300128(10)HUKR1368\n(01)00801741051869(17)300128(10)HUKS0774\n(01)00801741051869(17)300128(10)HUKU0238\n(01)00801741051869(17)300128(10)HUKU0242\n(01)00801741051869(17)300128(10)HUKU0247\n(01)00801741051869(17)300128(10)HUKU0253\n(01)00801741051869(17)300128(10)HUKU0254\n(01)00801741051869(17)300128(10)HUKU0266\n(01)00801741051869(17)300128(10)HUKU0280\n(01)00801741051869(17)300128(10)HUKU0283\n(01)00801741051869(17)300128(10)HUKU0284\n(01)00801741051869(17)300128(10)HUKU0290\n(01)00801741051869(17)300128(10)HUKU0293\n(01)00801741051869(17)300128(10)HUKU0294\n(01)00801741051869(17)300128(10)HUKU0298\n(01)00801741051869(17)300128(10)HUKU0312\n(01)00801741051869(17)300128(10)HUKU0339\n(01)00801741051869(17)300328(10)HUKU0340\n(01)00801741051869(17)300128(10)HUKU0344\n(01)00801741051869(17)300128(10)HUKU0354\n(01)00801741051869(17)300328(10)HUKV0549\n(01)00801741051869(17)300328(10)HUKV0576\n(01)00801741051869(17)300328(10)HUKW0148\nLot Number:\nHUKR1342\nHUKR1344\nHUKR1346\nHUKR1347\nHUKR1348\nHUKR1356\nHUKR1363\nHUKR1367\nHUKR1368\nHUKS0774\nHUKU0238\nHUKU0242\nHUKU0247\nHUKU0253\nHUKU0254\nHUKU0266\nHUKU0280\nHUKU0283\nHUKU0284\nHUKU0290\nHUKU0293\nHUKU0294\nHUKU0298\nHUKU0312\nHUKU0339\nHUKU0340\nHUKU0344\nHUKU0354\nHUKV0549\nHUKV0576\nHUKW0148\n\nProduct Name:Hickman 12 Fr Dual-Lumen CV Catheter, Peel-Apart Introducer kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600620CE\nUDI code:\n(01)00801741051913(17)291028(10)HUJY0302\n(01)00801741051913(17)291028(10)HUJY1095\n(01)00801741051913(17)291128(10)HUJZ1332\n(01)00801741051913(17)291128(10)HUJZ1336\n(01)00801741051913(17)291128(10)HUJZ1339\n(01)00801741051913(17)291128(10)HUJZ1340\n(01)00801741051913(17)300328(10)HUKR1349\n(01)00801741051913(17)300328(10)HUKR1364\n(01)00801741051913(17)300428(10)HUKS0784\n(01)00801741051913(17)300428(10)HUKS0806\n(01)00801741051913(17)300428(10)HUKS1217\n(01)00801741051913(17)230428(10)HUKS1218\n(01)00801741051913(17)300628(10)HUKU0259\n(01)00801741051913(17)300628(10)HUKU0351\n(01)00801741051913(17)300728(10)HUKV0349\n(01)00801741051913(17)300728(10)HUKV0567\n(01)00801741051913(17)300828(10)HUKW0534\nLot Number:\nHUJY0302\nHUJY1095\nHUJZ1332\nHUJZ1336\nHUJZ1339\nHUJZ1340\nHUKR1349\nHUKR1364\nHUKS0784\nHUKS0806\nHUKS1217\nHUKS1218\nHUKU0259\nHUKU0351\nHUKV0349\nHUKV0567\nHUKW0534\n\nProduct Name:Hickman 12.5 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0600650CE\nUDI code:\n(01)00801741051975(17)300228(10)HUKQ0535\n(01)00801741051975(17)300428(10)HUKS1474\n(01)00801741051975(17)300428(10)HUKS1483\n(01)00801741051975(17)300628(10)HUKU0313\n(01)00801741051975(17)300628(10)HUKU0317\n(01)00801741051975(17)300628(10)HUKU0328\n(01)00801741051975(17)300728(10)HUKV0354\n(01)00801741051975(17)300728(10)HUKV0371\n(01)00801741051975(17)300828(10)HUKW0171\n(01)00801741051975(17)300828(10)HUKW1283\nLot Number:\nHUKQ0535\nHUKS1474\nHUKS1483\nHUKU0313\nHUKU0317\nHUKU0328\nHUKV0354\nHUKV0371\nHUKW0171\nHUKW1283\n\nProduct Name:Hickman 10 Fr Triple-Lumen CV Catheter, Peel-Apart Introducer Kit with SureCuff Tissue Ingrowth Cuff\nProduct Catalog Number: 0606560CE\nUDI code:\n(01)00801741052019(17)290828(10)HUKR1370\n(01)00801741052019(17)290928(10)HUKS1219\n(01)00801741052019(17)300128(10)HUKU0255\n(01)00801741052019(17)290928(10)HUKU0324\n(01)00801741052019(17)300128(10)HUKV0578\n(01)00801741052019(17)300128(10)HUKW0172\n(01)00801741052019(17)300128(10)HUKW1315\nLot Number:\nHUKR1370\nHUKS1219\nHUKU0255\nHUKU0324\nHUKV0578\nHUKW0172\nHUKW1315",
      "firm_fei_number": "2020394",
      "recalling_firm": "Bard Peripheral Vascular Inc",
      "address_1": "1625 W 3rd St Bldg 1 850 W. Rio Salado Prkwy.",
      "address_2": "Bldg 1",
      "city": "Tempe",
      "state": "AZ",
      "postal_code": "85281-2438",
      "additional_info_contact": "480-303-2602",
      "reason_for_recall": "Due to damage to outer tray that can potentially compromise the sterile barrier",
      "root_cause_description": "Process control",
      "action": "On 01/12/1026, the firm sent via FedEx and/or email an \"URGENT: Medical Device Product Removal\" Letter informing customers that BD has identified via internal inspections that the packaging of some Hickman Catheter and Broviac Catheter kits may have damage present on the outer tray, potentially compromising the sterile barrier.  Affected products were distributed between 06/12/2025 to 11/28/2025.\n\nCustomers are instructed to:\n1. Discontinue use of product listed in the letter and immediately dispose of all affected product remaining in their possession in accordance with their local facility s process.\n2. Share this notification with all users within their facility network of the product to ensure they are also aware of this field action. If the affected products have been distributed further, forward this notification to ensure that these entities are contacted and informed of the recall.\n3. Complete 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 required product credit.\n4. Indicate on the response form the quantity of product identified at their facility and confirm that this product inventory was disposed of.\n\nFor questions or assistance, contact:\nPhone: 1-844-8BD-LIFE (1-844-823-5433)\nSay  Recall  when prompted Mon Fri 8:00am and 5:00pm CT\nor\nEmail: productcomplaints@bd.com",
      "product_quantity": "14,935 units",
      "distribution_pattern": "Worldwide - U.S. Nationwide distribution including in the states of 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, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. The countries of  Argentina, Australia, Brazil, Canada, Chile, Hong Kong, India, Japan, Korea, Mexico, Malaysia, Singapore, Thailand, Uruguay, Vietnam.",
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